Search

Your search keyword '"Horst, Heinz-August"' showing total 252 results
Start Over Author "Horst, Heinz-August"
252 results on '"Horst, Heinz-August"'

1. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study.

Author

Ravandi, Farhad, Ritchie, Ellen K, Sayar, Hamid, Lancet, Jeffrey E, Craig, Michael D, Vey, Norbert, Strickland, Stephen A, Schiller, Gary J, Jabbour, Elias, Erba, Harry P, Pigneux, Arnaud, Horst, Heinz-August, Recher, Christian, Klimek, Virginia M, Cortes, Jorge, Roboz, Gail J, Odenike, Olatoyosi, Thomas, Xavier, Havelange, Violaine, Maertens, Johan, Derigs, Hans-Günter, Heuser, Michael, Damon, Lloyd, Powell, Bayard L, Gaidano, Gianluca, Carella, Angelo-Michele, Wei, Andrew, Hogge, Donna, Craig, Adam R, Fox, Judith A, Ward, Renee, Smith, Jennifer A, Acton, Gary, Mehta, Cyrus, Stuart, Robert K, and Kantarjian, Hagop M

Subjects
Humans, Neoplasm Recurrence, Local, Thiazoles, Naphthyridines, Cytarabine, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Treatment Outcome, Remission Induction, Double-Blind Method, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Leukemia, Myeloid, Acute, Kaplan-Meier Estimate, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Hematology, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundSafe and effective treatments are urgently needed for patients with relapsed or refractory acute myeloid leukaemia. We investigated the efficacy and safety of vosaroxin, a first-in-class anticancer quinolone derivative, plus cytarabine in patients with relapsed or refractory acute myeloid leukaemia.MethodsThis phase 3, double-blind, placebo-controlled trial was undertaken at 101 international sites. Eligible patients with acute myeloid leukaemia were aged 18 years of age or older and had refractory disease or were in first relapse after one or two cycles of previous induction chemotherapy, including at least one cycle of anthracycline (or anthracenedione) plus cytarabine. Patients were randomly assigned 1:1 to vosaroxin (90 mg/m(2) intravenously on days 1 and 4 in a first cycle; 70 mg/m(2) in subsequent cycles) plus cytarabine (1 g/m(2) intravenously on days 1-5) or placebo plus cytarabine through a central interactive voice system with a permuted block procedure stratified by disease status, age, and geographical location. All participants were masked to treatment assignment. The primary efficacy endpoint was overall survival and the primary safety endpoint was 30-day and 60-day all-cause mortality. Efficacy analyses were done by intention to treat; safety analyses included all treated patients. This study is registered with ClinicalTrials.gov, number NCT01191801.FindingsBetween Dec 17, 2010, and Sept 25, 2013, 711 patients were randomly assigned to vosaroxin plus cytarabine (n=356) or placebo plus cytarabine (n=355). At the final analysis, median overall survival was 7·5 months (95% CI 6·4-8·5) in the vosaroxin plus cytarabine group and 6·1 months (5·2-7·1) in the placebo plus cytarabine group (hazard ratio 0·87, 95% CI 0·73-1·02; unstratified log-rank p=0·061; stratified p=0·024). A higher proportion of patients achieved complete remission in the vosaroxin plus cytarabine group than in the placebo plus cytarabine group (107 [30%] of 356 patients vs 58 [16%] of 355 patients, p

Published
2015

2. Midostaurin added to chemotherapy and continued single-agent maintenance therapy in acute myeloid leukemia with FLT3-ITD

Author

Schlenk, Richard F., Weber, Daniela, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Kindler, Thomas, Lübbert, Michael, Wolf, Dominik, Westermann, Jörg, Kraemer, Doris, Götze, Katharina S., Horst, Heinz-August, Krauter, Jürgen, Girschikofsky, Michael, Ringhoffer, Mark, Südhoff, Thomas, Held, Gerhard, Derigs, Hans-Günter, Schroers, Roland, Greil, Richard, Grießhammer, Martin, Lange, Elisabeth, Burchardt, Alexander, Martens, Uwe, Hertenstein, Bernd, Marretta, Lore, Heuser, Michael, Thol, Felicitas, Gaidzik, Verena I., Herr, Wolfgang, Krzykalla, Julia, Benner, Axel, Döhner, Konstanze, Ganser, Arnold, Paschka, Peter, and Döhner, Hartmut

Published
2019
Full Text
View/download PDF

4. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX

Author

Thaler, Josef, Greil, Richard, Gaenzer, Johannes, Eisterer, Wolfgang, Tschmelitsch, Joerg, Keil, Felix, Samonigg, Hellmut, Zabernigg, August, Schmid, Franz, Steger, Günther, Steinacher, Robert, Andel, Johannes, Jagdt, Björn, Lang, Alois, Fridrik, Michael, Függer, Reinhold, Hofbauer, Friedrich, Woell, Ewald, Geissler, Dietmar, Lenauer, Alfred, Prager, Manfred, D'Haens, Geert, Demolin, Gauthier, Kerger, Joseph, Deboever, Guido, Ghillebert, Gilbert, Polus, Marc, Van Cutsem, Eric, Kalantari, Hassan Rezaie, Delaunoit, Thierry, Goeminne, Jean Charles, Peeters, Marc, Vergauwe, Philippe, Houbiers, Ghislain, Humblet, Yves, Janssens, Jos, Schrijvers, Dirk, Vanderstraeten, Erik, Van Laethem, Jean-Luc, Vermorken, Jan, Van Daele, Daniel, Ferrante, Michel, Forget, Frederic, Hendlisz, Alain, Yilmaz, Mette, Nielsen, Svend Erik, Vestermark, Lene, Larsen, Jim, Zawadi, Mohamed-Ayman, Bouche, Olivier, Mineur, Laurent, Bennouna-Louridi, Jaafar, Dourthe, Louis Marie, Ychou, Marc, Boucher, Eveline, Taieb, Julien, Pezet, Denis, Desseigne, Francoise, Ducreux, Michel, Texereau, Patrick, Miglianico, Laurent, Rougier, Philippe, Fratte, Serge, Levache, Charles-Briac, Merrouche, Yacine, Ellis, Stephen, Locher, Christophe, Ramee, Jean-Francois, Garnier, Claire, Viret, Frederic, Chauffert, Bruno, Cojean-Zelek, Isabelle, Michel, Pierre, Lecaille, Cedric, Borel, Christian, Seitz, Jean-Francois, Smith, Denis, Lombard-Bohas, Catherine, Andre, Thierry, Gornet, Jean-Marc, Fein, Francine, Coulon-Sfairi, Marie-Aude, Kaminsky, Marie-Christine, Lagasse, Jean-Paul, Luet, Dominique, Etienne, Pierre-Luc, Gasmi, Mohamed, Vanoli, Andre, Nguyen, Suzanne, Aparicio, Thomas, Perrier, Hervé, Stremsdoerfer, Noel, Laplaige, Philippe, Arsene, Dominique, Auby, Dominique, Bedenne, Laurent, Coriat, Romain, Denis, Bernard, Geoffroy, Patrick, Piot, Gilles, Becouarn, Yves, Bordes, Gilbert, Deplanque, Gael, Dupuis, Olivier, Fruge, Frederic, Guimbaud, Rosine, Lecomte, Thierry, Lledo, Gérard, Sobhani, Iradej, Asnacios, Amani, Azzedine, Ahmed, Desauw, Christophe, Galais, Marie-Pierre, Gargot, Dany, Lam, You-Heng, Abakar-Mahamat, Abakar, Berdah, Jean-Francois, Catteau, Sylviane, Clavero-Fabri, Marie-Christine, Codoul, Jean-Francois, Legoux, Jean-Louis, Goldfain, Denis, Guichard, Pierre, Verge, Denis Pere, Provencal, Jocelyne, Vedrenne, Bruno, Brezault-Bonnet, Catherine, Cleau, Denis, Desir, Jean-Paul, Fallik, David, Garcia, Bruno, Gaspard, Marie-Hélène, Genet, Dominique, Hartwig, Johannes, Krummel, Yves, Budnik, Tamara Matysiak, Palascak-Juif, Vanessa, Randrianarivelo, Harizo, Rinaldi, Yves, Aleba, Albert, Darut-Jouve, Ariane, de Gramont, Aimery, Hamon, Herve, Wendehenne, Frederic, Matzdorff, Axel, Stahl, Michael Konrad, Schepp, Wolfgang, Burk, Martin, Mueller, Lothar, Folprecht, Gunnar, Geissler, Michael, Mantovani-Loeffler, Luisa, Hoehler, Thomas, Asperger, Walter, Kroening, Hendrik, von Weikersthal, Ludwig Fischer, Fuxius, Stefan, Groschek, Matthias, Meiler, Johannes, Trarbach, Tanja, Rauh, Jacqueline, Ziegenhagen, Nicolas, Kretzschmar, Albrecht, Graeven, Ullrich, Nusch, Arnd, von Wichert, Goetz, Hofheinz, Ralf-Dieter, Kleber, Gerhard, Schmidt, Karl-Heinz, Vehling-Kaiser, Ursula, Baum, Claudia, Schuette, Jochen, Haag, Georg Martin, Holtkamp, Wilhelm, Potenberg, Jochen, Reiber, Tobias, Schliesser, Georg, Schmoll, Hans-Joachim, Schneider-Kappus, Wolfgang, Abenhardt, Wolfgang, Denzlinger, Claudio, Henning, Jan, Marxsen, Bartscht, Derigs, Hans Guenter, Lambertz, Helmut, Becker-Boost, Ingulf, Caca, Karel, Constantin, Christian, Decker, Thomas, Eschenburg, Henning, Gabius, Sigrun, Hebart, Holger, Hoffmeister, Albrecht, Horst, Heinz-August, Kremers, Stephan, Leithaeuser, Malte, Mueller, Sebastian, Wagner, Siegfried, Daum, Severin, Schlegel, Frank, Stauch, Martina, Heinemann, Volker, Maiello, Evaristo, Latini, Luciano, Zaniboni, Alberto, Amadori, Dino, Aprile, Giuseppe, Barni, Sandro, Mattioli, Rodolfo, Martoni, Andrea, Passalacqua, Rodolfo, Nicolini, Mario, Pasquini, Enzo, Rabbi, Carla, Aitini, Enrico, Ravaioli, Alberto, Barone, Carlo, Biasco, Guido, Tamberi, Stefano, Gambi, Angelo, Verusio, Claudio, Marzola, Marina, Lelli, Giorgio, Boni, Corrado, Cascinu, Stefano, Bidoli, Paolo, Vaghi, Massimo, Cruciani, Giorgio, Di Costanzo, Francesco, Sobrero, Alberto, Mini, Enrico, Petrioli, Roberto, Aglietta, Massimo, Alabiso, Oscar, Capuzzo, Federico, Falcone, Alfredo, Corsi, Domenico Cristi, Labianca, Roberto, Salvagni, Stefania, Chiara, Silvana, Ciuffreda, Libero, Ferraù, Francesco, Giuliani, Francesco, Lonardi, Sara, Gebbia, Nicola, Mantovani, Giovanni, Sanches, Evaristo, Mellidez, Juan Carlos, Santos, Pedro, Freire, Joao, Sarmento, Cristina, Costa, Luis, Pinto, Antonio Moreira, Barroso, Sergio, Santo, Jorge Espirito, Guedes, Fátima, Monteiro, Amélia, Sa, Anabela, Furtado, Irene, Salazar, Ramon, Aguilar, Enrique Aranda, Herrero, Fernando Rivera, Tabernero, Josep, Valera, Javier Sastre, Ayerbes, Manuel Valladares, Batlle, Jaime Feliu, Gil, Silvia, Esteve, Albert Abad, Garcia-Giron, Carlos, Vivanco, Guillermo Lopez, Salvia, Antonia Salud, Orduña, Vicente Alonso, Garcia, Ruth Vera, Gallego, Javier, Sureda, Bartomeu Massuti, Remon, Jordi, Safont Aguilera, Maria Jose, Nogueras, Luis Cirera, Merino, Bernado Queralt, Castro, Cristina Gravalos, de Prado, Purificacion Martinez, Pericay, Carlos Pijaume, Figueiras, Manuel Constenla, Jordan, Inmaculada Guasch, Gome Reina, Maria Jose, Garcia, Amelia Lopez-Ladron, Garcia-Ramos, Antonio Arrivi, Cervantes, Andres, Martos, Carlos Fernandez, Gaspar, Eugenio Marcuello, Montero, Ines Cabezas, Emperador, Pilar Escudero, Carbonero, Ana Leon, Castillo, Manuel Gallen, Garcia, Teresa Garcia, Lopez, Jose Garcia, Flores, Encarnacion Gonzalez, Morales, Monica Guillot, Muñoz, Marta Llanos, Martín, Ana López, Maurel, Joan, Camara, Juan Carlos, Garcia, Rosario Dueñas, Salgado, Mercedes, Busquier, Isabel Hernandez, Ruiz, Teresa Checa, Muñoa, Adelaida Lacasta, Aliguer, Miquel Nogue, de Taranco, Amalia Velasco Ortiz, Ureña, Miguel Mendez, Gaspa, Ferran Losa, Ponce, Jose Juan, Roig, Carlos Bosch, Jimenez, Pedro Valero, Brotons, Antonio Galan, Rodriguez, Santiago Albiol, Martinez, Jose Ales, Ruiz, Liliana Canosa, Ruiz, Margarita Centelles, Bridgewater, John, Glynne-Jones, Rob, Tahir, Saad, Hickish, Tamas, Cassidy, Jim, Samuel, Leslie, Emile, Jean-François, Julié, Catherine, Le Malicot, Karine, Lepage, Come, Dimet, Stéphanie, Boulagnon-Rombi, Camille, Allard, Marc-Antoine, Penault-Llorca, Frédérique, Bennouna, Jaafar, and Laurent-Puig, Pierre

Published
2017
Full Text
View/download PDF

5. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial

Author

Hoelzer, Dieter, Walewski, Jan, Döhner, Hartmut, Viardot, Andreas, Hiddemann, Wolfgang, Spiekermann, Karsten, Serve, Hubert, Dührsen, Ulrich, Hüttmann, Andreas, Thiel, Eckhard, Dengler, Jolanta, Kneba, Michael, Schaich, Markus, Schmidt-Wolf, IngoG. H., Beck, Joachim, Hertenstein, Bernd, Reichle, Albrecht, Domanska-Czyz, Katarzyna, Fietkau, Rainer, Horst, Heinz-August, Rieder, Harald, Schwartz, Stefan, Burmeister, Thomas, and Gökbuget, Nicola

Published
2014
Full Text
View/download PDF

7. Secondary genetic lesions in acute myeloid leukemia with inv(16) or t(16;16): a study of the German-Austrian AML Study Group (AMLSG)

Author

Paschka, Peter, Du, Juan, Schlenk, Richard F., Gaidzik, Verena I., Bullinger, Lars, Corbacioglu, Andrea, Späth, Daniela, Kayser, Sabine, Schlegelberger, Brigitte, Krauter, Jürgen, Ganser, Arnold, Köhne, Claus-Henning, Held, Gerhard, von Lilienfeld-Toal, Marie, Kirchen, Heinz, Rummel, Mathias, Götze, Katharina, Horst, Heinz-August, Ringhoffer, Mark, Lübbert, Michael, Wattad, Mohammed, Salih, Helmut R., Kündgen, Andrea, Döhner, Hartmut, and Döhner, Konstanze

Published
2013
Full Text
View/download PDF

8. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia

Author

Kantarjian, Hagop, Stein, Anthony, Gökbuget, Nicola, Fielding, Adele K., Schuh, Andre C., Ribera, Josep-Maria, Wei, Andrew, Dombret, Hervé, Foà, Robin, Bassan, Renato, Arslan, Önder, Sanz, Miguel A., Bergeron, Julie, Demirkan, Fatih, Lech-Maranda, Ewa, Rambaldi, Alessandro, Thomas, Xavier, Horst, Heinz-August, Brüggemann, Monika, Klapper, Wolfram, Wood, Brent L., Fleishman, Alex, Nagorsen, Dirk, Holland, Christopher, Zimmerman, Zachary, and Topp, Max S.

Published
2017
Full Text
View/download PDF

9. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation

Author

Gökbuget, Nicola, Stanze, Daniel, Beck, Joachim, Diedrich, Helmut, Horst, Heinz-August, Hüttmann, Andreas, Kobbe, Guido, Kreuzer, Karl-Anton, Leimer, Lothar, Reichle, Albrecht, Schaich, Markus, Schwartz, Stefan, Serve, Hubert, Starck, Michael, Stelljes, Matthias, Stuhlmann, Reingard, Viardot, Andreas, Wendelin, Knut, Freund, Mathias, and Hoelzer, Dieter

Published
2012
Full Text
View/download PDF

10. Sequential treatment with rituximab followed by CHOP chemotherapy in adult B-cell post-transplant lymphoproliferative disorder (PTLD): the prospective international multicentre phase 2 PTLD-1 trial

Author

Trappe, Ralf, Oertel, Stephan, Leblond, Veronique, Mollee, Peter, Sender, Monica, Reinke, Petra, Neuhaus, Ruth, Lehmkuhl, Hans, Horst, Heinz August, Salles, Gilles, Morschhauser, Franck, Jaccard, Arnaud, Lamy, Thierry, Leithäuser, Malte, Zimmermann, Heiner, Anagnostopoulos, Ioannis, Raphael, Martine, Riess, Hanno, and Choquet, Sylvain

Published
2012
Full Text
View/download PDF

11. Addition of AEG35156 XIAP Antisense Oligonucleotide in Reinduction Chemotherapy Does Not Improve Remission Rates in Patients With Primary Refractory Acute Myeloid Leukemia in a Randomized Phase II Study

Author

Schimmer, Aaron D., Herr, Wolfgang, Hänel, Mathias, Borthakur, Gautham, Frankel, Arthur, Horst, Heinz-August, Martin, Sonja, Kassis, Jeannine, Desjardins, Pierre, Seiter, Karen, Fiedler, Walter, Noppeney, Richard, Giagounidis, Aristoteles, Jacob, Christine, Jolivet, Jacques, Tallman, Martin S., and Koschmieder, Steffen

Published
2011
Full Text
View/download PDF

12. Correction to: Treatment modifcation after starting cART in people living with HIV: retrospective analysis of the German ClinSurv HIV Cohort 2005–2017

Author

Stecher, Melanie, Schommers, Philipp Frederik, Kollan, Christian, Stoll, Matthias, Kuhlendahl, Frieder-Johan, Stellbrink, Hans‑Jürgen, Wasmuth, Jan‑Christian, Stephan, Christoph, Hamacher, Laura, Lehmann, Clara, Boesecke, Christoph, Bogner, Johannes, Esser, Stefan, Fritzsche, Carlos, Haberl, Annette, Schürmann, Dirk, Degen, Olaf, Horst, Heinz August, Hoffmann, Christian, Jensen, Björn-Erik Ole, Schwarze-Zander, Carolynne, Platten, Martin, Fätkenheuer, Gerd, Schmidt, Daniel, Gunsenheimer-Bartmeyer, Barbara, Vehreschild, Jörg Janne, and ClinSurv Study Group

Subjects
ddc:610
Abstract

Correction to: Infection (2020) 48:723–733 https://doi.org/10.1007/s15010-020-01469-6. The original version of this article unfortunately contained a mistake. In this article the authors Dirk Schürmann at affiliation Charité, University Medicine, Berlin, Olaf Degen at affiliation University Clinic Hamburg Eppendorf, Hamburg and Heinz-August Horst at affiliation University Hospital Schleswig–Holstein, Kiel, Germany were missing from the author list. The original article has been corrected.

Published
2021

13. Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial

Author

Döhner, Hartmut, primary, Symeonidis, Argiris, additional, Deeren, Dries, additional, Demeter, Judit, additional, Sanz, Miguel A., additional, Anagnostopoulos, Achilles, additional, Esteve, Jordi, additional, Fiedler, Walter, additional, Porkka, Kimmo, additional, Kim, Hee-Je, additional, Lee, Je-Hwan, additional, Usuki, Kensuke, additional, D'Ardia, Stefano, additional, Won Jung, Chul, additional, Salamero, Olga, additional, Horst, Heinz-August, additional, Recher, Christian, additional, Rousselot, Philippe, additional, Sandhu, Irwindeep, additional, Theunissen, Koen, additional, Thol, Felicitas, additional, Döhner, Konstanze, additional, Teleanu, Veronica, additional, DeAngelo, Daniel J., additional, Naoe, Tomoki, additional, Sekeres, Mikkael A., additional, Belsack, Valerie, additional, Ge, Miaomiao, additional, Taube, Tillmann, additional, and Ottmann, Oliver G., additional

Published
2021
Full Text
View/download PDF

14. Treatment modifcation after starting cART in people living with HIV: retrospective analysis of the German ClinSurv HIV Cohort 2005-2017 (vol 48, pg 723, 2020)

Author

Stecher, Melanie, Schommers, Philipp, Kollan, Christian, Stoll, Matthias, Kuhlendahl, Frieder, Stellbrink, Hans-Juergen, Wasmuth, Jan-Christian, Stephan, Christoph, Hamacher, Laura, Lehmann, Clara, Boesecke, Christoph, Bogner, Johannes, Esser, Stefan, Fritzsche, Carlos, Haberl, Annette, Schuermann, Dirk, Degen, Olaf, Horst, Heinz-August, Hoffmann, Christian, Jensen, Bjoern, Schwarze-Zander, Carolynne, Platten, Martin, Faetkenheuer, Gerd, Schmidt, Daniel, Gunsenheimer-Bartmeyer, Barbara, Vehreschild, Joerg Janne, Stecher, Melanie, Schommers, Philipp, Kollan, Christian, Stoll, Matthias, Kuhlendahl, Frieder, Stellbrink, Hans-Juergen, Wasmuth, Jan-Christian, Stephan, Christoph, Hamacher, Laura, Lehmann, Clara, Boesecke, Christoph, Bogner, Johannes, Esser, Stefan, Fritzsche, Carlos, Haberl, Annette, Schuermann, Dirk, Degen, Olaf, Horst, Heinz-August, Hoffmann, Christian, Jensen, Bjoern, Schwarze-Zander, Carolynne, Platten, Martin, Faetkenheuer, Gerd, Schmidt, Daniel, Gunsenheimer-Bartmeyer, Barbara, and Vehreschild, Joerg Janne

Published
2021

15. Correction to: Treatment modifcation after starting cART in people living with HIV: retrospective analysis of the German ClinSurv HIV Cohort 2005–2017

Author

ClinSurv Study Group, Stecher, Melanie, Schommers, Philipp Frederik, Kollan, Christian, Stoll, Matthias, Kuhlendahl, Frieder-Johan, Stellbrink, Hans‑Jürgen, Wasmuth, Jan‑Christian, Stephan, Christoph, Hamacher, Laura, Lehmann, Clara, Boesecke, Christoph, Bogner, Johannes, Esser, Stefan, Fritzsche, Carlos, Haberl, Annette, Schürmann, Dirk, Degen, Olaf, Horst, Heinz August, Hoffmann, Christian, Jensen, Björn-Erik Ole, Schwarze-Zander, Carolynne, Platten, Martin, Fätkenheuer, Gerd, Schmidt, Daniel, Gunsenheimer-Bartmeyer, Barbara, Vehreschild, Jörg Janne, ClinSurv Study Group, Stecher, Melanie, Schommers, Philipp Frederik, Kollan, Christian, Stoll, Matthias, Kuhlendahl, Frieder-Johan, Stellbrink, Hans‑Jürgen, Wasmuth, Jan‑Christian, Stephan, Christoph, Hamacher, Laura, Lehmann, Clara, Boesecke, Christoph, Bogner, Johannes, Esser, Stefan, Fritzsche, Carlos, Haberl, Annette, Schürmann, Dirk, Degen, Olaf, Horst, Heinz August, Hoffmann, Christian, Jensen, Björn-Erik Ole, Schwarze-Zander, Carolynne, Platten, Martin, Fätkenheuer, Gerd, Schmidt, Daniel, Gunsenheimer-Bartmeyer, Barbara, and Vehreschild, Jörg Janne

Abstract

Correction to: Infection (2020) 48:723–733 https://doi.org/10.1007/s15010-020-01469-6. The original version of this article unfortunately contained a mistake. In this article the authors Dirk Schürmann at affiliation Charité, University Medicine, Berlin, Olaf Degen at affiliation University Clinic Hamburg Eppendorf, Hamburg and Heinz-August Horst at affiliation University Hospital Schleswig–Holstein, Kiel, Germany were missing from the author list. The original article has been corrected.

Published
2021

16. Blinatumomab as first salvage versus second or later salvage in adults with relapsed/refractory B‐cell precursor acute lymphoblastic leukemia: Results of a pooled analysis

Author

Topp, Max S., primary, Stein, Anthony S., additional, Gökbuget, Nicola, additional, Horst, Heinz‐August, additional, Boissel, Nicolas, additional, Martinelli, Giovanni, additional, Kantarjian, Hagop, additional, Brüggemann, Monika, additional, Chen, Yuqi, additional, and Zugmaier, Gerhard, additional

Published
2021
Full Text
View/download PDF

17. Liposomal amphotericin B as initial therapy for invasive mold infection: a randomized trial comparing a high-loading dose regimen with standard dosing (AmBiLoad Trial)

Author

Cornely, Oliver A., Maertens, Johan, Bresnik, Mark, Ebrahimi, Ramin, Ullmann, Andrew J., Bouza, Emilio, Heussel, Claus Peter, Lortholary, Olivier, Rieger, Christina, Boehme, Angelika, Aoun, Mickael, Horst, Heinz-August, Thiebaut, Anne, Ruhnke, Markus, Reichert, Dietmar, Vianelli, Nicola, Krause, Stefan W., Olavarria, Eduardo, and Herbrecht, Raoul

Subjects
Amphotericin B -- Dosage and administration, Amphotericin B -- Research, Aspergillosis -- Care and treatment, Health, Health care industry
Published
2007

18. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia

Author

Gökbuget, Nicola, Zugmaier, Gerhard, Dombret, Hervé, Stein, Anthony, Bonifacio, Massimiliano, Graux, Carlos, Faul, Christoph, Brüggemann, Monika, Taylor, Kate, Mergen, Noemi, Reichle, Albrecht, Horst, Heinz August, Havelange, Violaine, Topp, Max S., Bargou, Ralf C., Gökbuget, Nicola, Zugmaier, Gerhard, Dombret, Hervé, Stein, Anthony, Bonifacio, Massimiliano, Graux, Carlos, Faul, Christoph, Brüggemann, Monika, Taylor, Kate, Mergen, Noemi, Reichle, Albrecht, Horst, Heinz August, Havelange, Violaine, Topp, Max S., and Bargou, Ralf C.

Abstract

Minimal residual disease (MRD) is the strongest predictor of relapse in B-cell precursor acute lymphoblastic leukemia (BCP-ALL). In BLAST study (NCT01207388), adults with BCP-ALL in remission with MRD after chemotherapy received blinatumomab, a CD19 BiTE® immuno-oncotherapy, 15 µg/m2/day for up to four 6-week cycles (4 weeks continuous infusion, 2 weeks off). Survival was evaluated for 110 patients, including 74 who received HSCT in continuous complete remission. With a median follow-up of 59·8 months, median survival (months) was 36·5 (95% CI: 22.0–not reached [NR]). Median survival was NR (29.5–NR) for complete MRD responders (n = 84) and 14.4 (3.8–32.3) for MRD non-responders (n = 23; p = 0.002); after blinatumomab and HSCT, median survival was NR (25.7–NR) (n = 61) and 16.5 (1.1–NR) (n = 10; p = 0.065), respectively. This final analysis suggests complete MRD response during blinatumomab treatment is curative. Post-hoc analysis of study data suggests while post blinatumomab HSCT may be beneficial in appropriate patients, long-term survival without HSCT is also possible.

Published
2020

22. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia

Author

Gökbuget, Nicola, primary, Zugmaier, Gerhard, additional, Dombret, Hervé, additional, Stein, Anthony, additional, Bonifacio, Massimiliano, additional, Graux, Carlos, additional, Faul, Christoph, additional, Brüggemann, Monika, additional, Taylor, Kate, additional, Mergen, Noemi, additional, Reichle, Albrecht, additional, Horst, Heinz-August, additional, Havelange, Violaine, additional, Topp, Max S., additional, and Bargou, Ralf C., additional

Published
2020
Full Text
View/download PDF

25. Erratum to 'Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia'[Blood. 2018;131(14):1522-1531]

Author

Gökbuget, Nicola, Dombret, Hervé, Bonifacio, Massimiliano, Reichle, Albrecht, Graux, Carlos, Faul, Christoph, Diedrich, Helmut, Topp, Max S, Brüggemann, Monika, Horst, Heinz-August, Havelange, Violaine, Stieglmaier, Julia, Wessels, Hendrik, Haddad, Vincent, Benjamin, Jonathan E, Zugmaier, Gerhard, Nagorsen, Dirk, Bargou, Ralf C, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/MEXP - Médecine expérimentale, UCL - (MGD) Service d'hématologie, UCL - (SLuc) Service d'hématologie, and UCL - (SLuc) Centre du cancer

Abstract

On page 1526 of the 5 April 2018 issue, the scale of Figure 3B’s y-axis is inaccurate. The corrected Figure 3B is shown below. The error has been corrected in the online version of the article.

Published
2019

31. Hematopoietic stem cell involvement in BCR-ABL1–positive ALL as a potential mechanism of resistance to blinatumomab therapy

Author

Nagel, Inga, Bartels, Marius, Duell, Johannes, Oberg, Hans-Heinrich, Ussat, Sandra, Bruckmueller, Henrike, Ottmann, Oliver, Pfeifer, Heike, Trautmann, Heiko, Gökbuget, Nicola, Caliebe, Almuth, Kabelitz, Dieter, Kneba, Michael, Horst, Heinz-August, Hoelzer, Dieter, Topp, Max S., Cascorbi, Ingolf, Siebert, Reiner, and Brüggemann, Monika

Published
2017
Full Text
View/download PDF

32. Physical and mental health in HIV-infected patients with virological success and long-term exposure to antiretroviral therapy.

Author

Sabranski, Michael, Erdbeer, Gesa, Sonntag, Ina, Stoehr, Albrecht, Horst, Heinz-August, Plettenberg, Andreas, Lebherz, Lisa, Stellbrink, Hans-Jürgen, and Hoffmann, Christian

Subjects
HIV-positive persons, HEALTH facilities, VIRAL load, CROSS-sectional method, MULTIVARIATE analysis, MENTAL health, ANTIRETROVIRAL agents, LIFE skills, QUALITY of life, QUESTIONNAIRES, EMPLOYMENT, PSYCHOSOCIAL factors
Abstract

In people living with HIV (PLWH), a decade-long antiretroviral therapy (ART) poses new challenges regarding physical and mental health. The aim of this cross-sectional study is to investigate the health-related quality of life (HRQOL) in adult HIV-infected patients with viral suppression and an ART exposure for at least 5 years in three German HIV centers. Patients were evaluated by the ACTG Augmented Symptoms Distress Module (ASDM) and the SF-12 Health Survey. Among 894 patients, symptom-related distress was highly prevalent. The most common symptoms were fatigue, insomnia, sadness and depression, sexual dysfunction, and changes in body appearance. In the multivariate analysis, ART duration, age and depression were significantly associated with a higher overall symptom summary score. Self-reported mean SF-12 scores were lower for mental health and younger patients compared to the standard random sample of a healthy German population. Depression and occupational status were significantly related to a lower physical component summary score, by contrast older age was associated with higher scores in the mental component summary, implying more favorable mental health status. In this large group of PLWH, the degree of symptom-related distress was high. Mental and physical health should be considered an integral part of ongoing HIV care. [ABSTRACT FROM AUTHOR]

Published
2021
Full Text
View/download PDF

33. Blinatumomab for minimal residual disease in adults with B-precursor acute lymphoblastic leukemia.

Author

UCL - (MGD) Service d'hématologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre du cancer, UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/MEXP - Médecine expérimentale, Gökbuget, Nicola, Dombret, Hervé, Bonifacio, Massimiliano, Reichle, Albrecht, Graux, Carlos, Faul, Christoph, Diedrich, Helmut, Topp, Max S, Brüggemann, Monika, Horst, Heinz-August, Havelange, Violaine, Stieglmaier, Julia, Wessels, Hendrik, Haddad, Vincent, Benjamin, Jonathan E, Zugmaier, Gerhard, Nagorsen, Dirk, Bargou, Ralf C, UCL - (MGD) Service d'hématologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre du cancer, UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/MEXP - Médecine expérimentale, Gökbuget, Nicola, Dombret, Hervé, Bonifacio, Massimiliano, Reichle, Albrecht, Graux, Carlos, Faul, Christoph, Diedrich, Helmut, Topp, Max S, Brüggemann, Monika, Horst, Heinz-August, Havelange, Violaine, Stieglmaier, Julia, Wessels, Hendrik, Haddad, Vincent, Benjamin, Jonathan E, Zugmaier, Gerhard, Nagorsen, Dirk, and Bargou, Ralf C

Abstract

Approximately 30-50% of adults with acute lymphoblastic leukemia (ALL) in hematologic complete remission following multiagent therapy exhibit minimal residual disease (MRD) by reverse transcriptase-polymerase chain reaction or flow cytometry. MRD is the strongest predictor of relapse in ALL. In this open-label, single-arm study, adults with B-cell precursor ALL in hematologic complete remission with MRD (≥10-3) received blinatumomab 15 µg/m2/day by continuous intravenous infusion for up to four cycles. Patients could undergo allogeneic hematopoietic stem cell transplantation any time after cycle 1. The primary endpoint was complete MRD response status after one cycle of blinatumomab. One hundred sixteen patients received blinatumomab. Eighty-eight of 113 evaluable patients (78%) achieved a complete MRD response. In the subgroup of 110 patients with Philadelphia-chromosome negative ALL in hematologic remission, the Kaplan-Meier estimate of relapse-free survival (RFS) at 18 months was 53%. Median overall survival was 36.5 months. In a landmark analysis, complete MRD responders had longer relapse-free survival (23.6 vs 5.7 months; P=0.002) and overall survival (OS) (38.9 vs 12.5 months; P=0.002) compared with MRD nonresponders. Adverse events were consistent with previous studies of blinatumomab. Twelve (10%) patients and three (3%) patients had grade 3 or 4 neurologic events, respectively. Four (3%) patients had cytokine release syndrome (two grade 1 and two grade 3), all during cycle 1. Following treatment with blinatumomab in a population of patients with MRD-positive B-cell precursor ALL, the majority achieved a complete MRD response, which was associated with significantly longer RFS and OS compared with MRD nonresponders. The study is registered to https://clinicaltrials.gov as NCT01207388.

Published
2018

34. Long‐term survival of patients with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab.

Author

Topp, Max S., Gökbuget, Nicola, Zugmaier, Gerhard, Stein, Anthony S., Dombret, Hervé, Chen, Yuqi, Ribera, Josep‐Maria, Bargou, Ralf C., Horst, Heinz‐August, and Kantarjian, Hagop M.

Subjects
LYMPHOBLASTIC leukemia, ACUTE leukemia, HEMATOPOIETIC stem cell transplantation
Abstract

Background: Blinatumomab is a CD19 BiTE (bispecific T‐cell engager) immuno‐oncology therapy that mediates the lysis of cells expressing CD19. Methods: A pooled analysis of long‐term follow‐up data from 2 phase 2 studies that evaluated blinatumomab in heavily pretreated adults with Philadelphia chromosome–negative, relapsed/refractory B‐cell precursor acute lymphoblastic leukemia was conducted. Results: A total of 259 patients were included in the analysis. The median overall survival (OS) among all patients, regardless of response, was 7.5 months (95% confidence interval [CI], 5.5‐8.5 months); the median follow‐up time for OS was 36.0 months (range, 0.3‐60.8 months). The median relapse‐free survival (RFS) among patients who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) in the first 2 cycles (n = 123) was 7.7 months (95% CI, 6.2‐10.0 months); the median follow‐up time for RFS was 35.0 months (range, 9.5‐59.5 months). OS and RFS plateaued with 3‐year rates of 17.7% and 23.4%, respectively. The cumulative incidence function of the time to relapse, with death not due to relapse considered a competing risk, for patients who achieved a CR/CRh within 2 cycles of treatment also plateaued with a 3‐year relapse rate of 59.3%. For patients who achieved a CR/CRh with blinatumomab followed by allogeneic hematopoietic stem cell transplantation while in continuous CR, the median OS was 18.1 months (95% CI, 10.3‐30.0 months) with a 3‐year survival rate of 37.2%. Conclusions: These data suggest that long‐term survival is possible after blinatumomab therapy. Lay Summary: Immuno‐oncology therapies such as blinatumomab activate the patient's own immune system to kill cancer cells.This study combined follow‐up data from 2 blinatumomab‐related clinical trials to evaluate long‐term survival in patients with relapsed and/or refractory B‐cell precursor acute lymphoblastic leukemia at high risk for unfavorable outcomes.Among patients who achieved a deep response with blinatumomab, one‐third lived 3 years or longer. These findings suggest that long‐term survival is possible after treatment with blinatumomab. Patients achieving remission after blinatumomab can have a durable response. The survival plateau indicates a high probability of a cure in those patients responding to blinatumomab and alive after 3 years. [ABSTRACT FROM AUTHOR]

Published
2021
Full Text
View/download PDF

35. Immunological recovery in tuberculosis/HIV co-infected patients on antiretroviral therapy : Implication for tuberculosis preventive therapy

Author

Karo, Basel, Krause, Gérard, Castell, Stefanie, Kollan, Christian, Hamouda, Osamah, Haas, Walter, Kühne, Andrea, Arastéh, Keikawus, Bergmann, Frank J., Warncke, M., Rockstroh, Jürgen Kurt, Wasmuth, Jan Christian, Hass, S., Jensen, Björn Erik Ole, Feind, Cecilie, Esser, Stefan, Schenk-Westkamp, Pia, Stephan, Christoph J., Haberl, Annette E., Schott, P., Plettenberg, Andreas, Kuhlendahl, F., Stellbrink, Hans Jürgen, Adam, Axel, Schewe, Knud, Fenske, Stefan, Buhk, Thomas H., Hoffmann, Christian J., Radzuweit, D., Mainka, A., Degen, Olaf, Franz, M., Treffler, Natascha, Stoll, Matthias, Gerschmann, R. Beider S., Hoeper, Kirsten, Horst, Heinz August, Trautmann, S., Fätkenheuer, Gerd, Gillor, Daniel, Bogner, Johannes Richard, Sonntag, B., Salzberger, Bernd, and Fritzsche, Carlos

Subjects
Male, 0301 basic medicine, Medizin, HIV Infections, CD8-Positive T-Lymphocytes, Cohort Studies, 0302 clinical medicine, immune system diseases, Antiretroviral Therapy, Highly Active, Germany, 030212 general & internal medicine, Immune recovery, Coinfection, Incidence, Incidence (epidemiology), virus diseases, HIV/aids, Middle Aged, Viral Load, Antiretroviral therapy, Infectious Diseases, Cohort, Female, Viral load, Research Article, Cohort study, Adult, Cart, medicine.medical_specialty, Tuberculosis, 030106 microbiology, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Acquired immunodeficiency syndrome (AIDS), Internal medicine, mental disorders, medicine, Humans, lcsh:RC109-216, Developed country, AIDS-Related Opportunistic Infections, business.industry, Antibiotic Prophylaxis, medicine.disease, CD4 Lymphocyte Count, nervous system, Immunology, business, Biomarkers
Abstract

Background Understanding the immune response to combination antiretroviral therapy (cART) is essential for a clear approach to tuberculosis (TB) preventive therapy. We investigated the immunological recovery in cART-treated HIV-infected patients developing TB compared to those who remained free of TB. Methods We extracted data of HIV-infected patients from a multicenter cohort for the HIV clinical surveillance in Germany. No patients included in our study had TB at the beginning of the observation. Using a longitudinal mixed model, we assessed the differences in the mean change of biomarkers (CD4+ cell count, CD8+ cell count, CD4:CD8 ratio and viral load) since cART initiation in patients who remained free of TB vs. those developing TB. To detect the best-fit trajectories of the immunological biomarkers, we applied a multivariable fractional polynomials model. Results We analyzed a total of 10,671 HIV-infected patients including 139 patients who developed TB during follow-up. The highest TB incidences were observed during the first two years since cART initiation (0.32 and 0.50 per 100 person-years). In an adjusted multivariable mixed model, we found that the average change in CD4+ cell count recovery was significantly greater by 33 cells/μl in patients who remained free of TB compared with those developing TB. After the initial three months of cART, 65.6% of patients who remaining free of TB achieved CD4+ count of ≥400 cells/μl, while only 11.3% of patients developing TB reached this immunological status after the three months of cART. We found no differences in the average change of CD8+ cell count, CD4:CD8 ratio or viral load between the two-patient groups. Conclusion All HIV-infected patients responded to cART. However, patients developing TB showed reduced recovery in CD4+ cell count and this might partly explain the incident TB in HIV-infected patients receiving cART. These findings reinforce the importance of adjunctive TB preventive therapy for patients with reduced recovery in CD4+ cell count.

Published
2017

36. Monitoring of FLT3 Phosphorylation and FLT3 Ligand Levels in Patients with FLT3-ITD Mutated Acute Myeloid Leukemia (AML) Treated with Midostaurin within the AMLSG 16-10 Trial of the German-Austrian Study Group

Author

Theis, Frauke, primary, Weber, Daniela, additional, Rücker, Frank G., additional, Paschka, Peter, additional, Gaidzik, Verena I., additional, Thol, Felicitas, additional, Heuser, Michael, additional, Fiedler, Walter, additional, Wulf, Gerald, additional, Lübbert, Michael, additional, Salih, Helmut R., additional, Schroeder, Thomas Michael, additional, Götze, Katharina S., additional, Salwender, Hans Jürgen, additional, Kindler, Thomas, additional, Horst, Heinz-August, additional, Ringhoffer, Mark, additional, Wolf‎, Dominik, additional, Krauter, Jürgen, additional, Schlenk, Richard F., additional, Bullinger, Lars, additional, Ganser, Arnold, additional, Döhner, Hartmut, additional, and Döhner, Konstanze, additional

Published
2018
Full Text
View/download PDF

37. Phase 3 results for vosaroxin/cytarabine in the subset of patients ≥60 years old with refractory/early relapsed acute myeloid leukemia

Author

Ravandi, Farhad, primary, Ritchie, Ellen K., additional, Sayar, Hamid, additional, Lancet, Jeffrey E., additional, Craig, Michael D., additional, Vey, Norbert, additional, Strickland, Stephen A., additional, Schiller, Gary J., additional, Jabbour, Elias, additional, Pigneux, Arnaud, additional, Horst, Heinz-August, additional, Récher, Christian, additional, Klimek, Virginia M., additional, Cortes, Jorge E., additional, Carella, Angelo-Michele, additional, Egyed, Miklos, additional, Krug, Utz, additional, Fox, Judith A., additional, Craig, Adam R., additional, Ward, Renee, additional, Smith, Jennifer A., additional, Acton, Gary, additional, Kantarjian, Hagop M., additional, and Stuart, Robert K., additional

Published
2018
Full Text
View/download PDF

38. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX

Author

Emile, Jean-François, primary, Julié, Catherine, additional, Le Malicot, Karine, additional, Lepage, Come, additional, Tabernero, Josep, additional, Mini, Enrico, additional, Folprecht, Gunnar, additional, Van Laethem, Jean-Luc, additional, Dimet, Stéphanie, additional, Boulagnon-Rombi, Camille, additional, Allard, Marc-Antoine, additional, Penault-Llorca, Frédérique, additional, Bennouna, Jaafar, additional, Laurent-Puig, Pierre, additional, Taieb, Julien, additional, Thaler, Josef, additional, Greil, Richard, additional, Gaenzer, Johannes, additional, Eisterer, Wolfgang, additional, Tschmelitsch, Joerg, additional, Keil, Felix, additional, Samonigg, Hellmut, additional, Zabernigg, August, additional, Schmid, Franz, additional, Steger, Günther, additional, Steinacher, Robert, additional, Andel, Johannes, additional, Jagdt, Björn, additional, Lang, Alois, additional, Fridrik, Michael, additional, Függer, Reinhold, additional, Hofbauer, Friedrich, additional, Woell, Ewald, additional, Geissler, Dietmar, additional, Lenauer, Alfred, additional, Prager, Manfred, additional, D'Haens, Geert, additional, Demolin, Gauthier, additional, Kerger, Joseph, additional, Deboever, Guido, additional, Ghillebert, Gilbert, additional, Polus, Marc, additional, Van Cutsem, Eric, additional, Kalantari, Hassan Rezaie, additional, Delaunoit, Thierry, additional, Goeminne, Jean Charles, additional, Peeters, Marc, additional, Vergauwe, Philippe, additional, Houbiers, Ghislain, additional, Humblet, Yves, additional, Janssens, Jos, additional, Schrijvers, Dirk, additional, Vanderstraeten, Erik, additional, Vermorken, Jan, additional, Van Daele, Daniel, additional, Ferrante, Michel, additional, Forget, Frederic, additional, Hendlisz, Alain, additional, Yilmaz, Mette, additional, Nielsen, Svend Erik, additional, Vestermark, Lene, additional, Larsen, Jim, additional, Zawadi, Mohamed-Ayman, additional, Bouche, Olivier, additional, Mineur, Laurent, additional, Bennouna-Louridi, Jaafar, additional, Dourthe, Louis Marie, additional, Ychou, Marc, additional, Boucher, Eveline, additional, Pezet, Denis, additional, Desseigne, Francoise, additional, Ducreux, Michel, additional, Texereau, Patrick, additional, Miglianico, Laurent, additional, Rougier, Philippe, additional, Fratte, Serge, additional, Levache, Charles-Briac, additional, Merrouche, Yacine, additional, Ellis, Stephen, additional, Locher, Christophe, additional, Ramee, Jean-Francois, additional, Garnier, Claire, additional, Viret, Frederic, additional, Chauffert, Bruno, additional, Cojean-Zelek, Isabelle, additional, Michel, Pierre, additional, Lecaille, Cedric, additional, Borel, Christian, additional, Seitz, Jean-Francois, additional, Smith, Denis, additional, Lombard-Bohas, Catherine, additional, Andre, Thierry, additional, Gornet, Jean-Marc, additional, Fein, Francine, additional, Coulon-Sfairi, Marie-Aude, additional, Kaminsky, Marie-Christine, additional, Lagasse, Jean-Paul, additional, Luet, Dominique, additional, Etienne, Pierre-Luc, additional, Gasmi, Mohamed, additional, Vanoli, Andre, additional, Nguyen, Suzanne, additional, Aparicio, Thomas, additional, Perrier, Hervé, additional, Stremsdoerfer, Noel, additional, Laplaige, Philippe, additional, Arsene, Dominique, additional, Auby, Dominique, additional, Bedenne, Laurent, additional, Coriat, Romain, additional, Denis, Bernard, additional, Geoffroy, Patrick, additional, Piot, Gilles, additional, Becouarn, Yves, additional, Bordes, Gilbert, additional, Deplanque, Gael, additional, Dupuis, Olivier, additional, Fruge, Frederic, additional, Guimbaud, Rosine, additional, Lecomte, Thierry, additional, Lledo, Gérard, additional, Sobhani, Iradej, additional, Asnacios, Amani, additional, Azzedine, Ahmed, additional, Desauw, Christophe, additional, Galais, Marie-Pierre, additional, Gargot, Dany, additional, Lam, You-Heng, additional, Abakar-Mahamat, Abakar, additional, Berdah, Jean-Francois, additional, Catteau, Sylviane, additional, Clavero-Fabri, Marie-Christine, additional, Codoul, Jean-Francois, additional, Legoux, Jean-Louis, additional, Goldfain, Denis, additional, Guichard, Pierre, additional, Verge, Denis Pere, additional, Provencal, Jocelyne, additional, Vedrenne, Bruno, additional, Brezault-Bonnet, Catherine, additional, Cleau, Denis, additional, Desir, Jean-Paul, additional, Fallik, David, additional, Garcia, Bruno, additional, Gaspard, Marie-Hélène, additional, Genet, Dominique, additional, Hartwig, Johannes, additional, Krummel, Yves, additional, Budnik, Tamara Matysiak, additional, Palascak-Juif, Vanessa, additional, Randrianarivelo, Harizo, additional, Rinaldi, Yves, additional, Aleba, Albert, additional, Darut-Jouve, Ariane, additional, de Gramont, Aimery, additional, Hamon, Herve, additional, Wendehenne, Frederic, additional, Matzdorff, Axel, additional, Stahl, Michael Konrad, additional, Schepp, Wolfgang, additional, Burk, Martin, additional, Mueller, Lothar, additional, Geissler, Michael, additional, Mantovani-Loeffler, Luisa, additional, Hoehler, Thomas, additional, Asperger, Walter, additional, Kroening, Hendrik, additional, von Weikersthal, Ludwig Fischer, additional, Fuxius, Stefan, additional, Groschek, Matthias, additional, Meiler, Johannes, additional, Trarbach, Tanja, additional, Rauh, Jacqueline, additional, Ziegenhagen, Nicolas, additional, Kretzschmar, Albrecht, additional, Graeven, Ullrich, additional, Nusch, Arnd, additional, von Wichert, Goetz, additional, Hofheinz, Ralf-Dieter, additional, Kleber, Gerhard, additional, Schmidt, Karl-Heinz, additional, Vehling-Kaiser, Ursula, additional, Baum, Claudia, additional, Schuette, Jochen, additional, Haag, Georg Martin, additional, Holtkamp, Wilhelm, additional, Potenberg, Jochen, additional, Reiber, Tobias, additional, Schliesser, Georg, additional, Schmoll, Hans-Joachim, additional, Schneider-Kappus, Wolfgang, additional, Abenhardt, Wolfgang, additional, Denzlinger, Claudio, additional, Henning, Jan, additional, Marxsen, Bartscht, additional, Derigs, Hans Guenter, additional, Lambertz, Helmut, additional, Becker-Boost, Ingulf, additional, Caca, Karel, additional, Constantin, Christian, additional, Decker, Thomas, additional, Eschenburg, Henning, additional, Gabius, Sigrun, additional, Hebart, Holger, additional, Hoffmeister, Albrecht, additional, Horst, Heinz-August, additional, Kremers, Stephan, additional, Leithaeuser, Malte, additional, Mueller, Sebastian, additional, Wagner, Siegfried, additional, Daum, Severin, additional, Schlegel, Frank, additional, Stauch, Martina, additional, Heinemann, Volker, additional, Maiello, Evaristo, additional, Latini, Luciano, additional, Zaniboni, Alberto, additional, Amadori, Dino, additional, Aprile, Giuseppe, additional, Barni, Sandro, additional, Mattioli, Rodolfo, additional, Martoni, Andrea, additional, Passalacqua, Rodolfo, additional, Nicolini, Mario, additional, Pasquini, Enzo, additional, Rabbi, Carla, additional, Aitini, Enrico, additional, Ravaioli, Alberto, additional, Barone, Carlo, additional, Biasco, Guido, additional, Tamberi, Stefano, additional, Gambi, Angelo, additional, Verusio, Claudio, additional, Marzola, Marina, additional, Lelli, Giorgio, additional, Boni, Corrado, additional, Cascinu, Stefano, additional, Bidoli, Paolo, additional, Vaghi, Massimo, additional, Cruciani, Giorgio, additional, Di Costanzo, Francesco, additional, Sobrero, Alberto, additional, Petrioli, Roberto, additional, Aglietta, Massimo, additional, Alabiso, Oscar, additional, Capuzzo, Federico, additional, Falcone, Alfredo, additional, Corsi, Domenico Cristi, additional, Labianca, Roberto, additional, Salvagni, Stefania, additional, Chiara, Silvana, additional, Ciuffreda, Libero, additional, Ferraù, Francesco, additional, Giuliani, Francesco, additional, Lonardi, Sara, additional, Gebbia, Nicola, additional, Mantovani, Giovanni, additional, Sanches, Evaristo, additional, Mellidez, Juan Carlos, additional, Santos, Pedro, additional, Freire, Joao, additional, Sarmento, Cristina, additional, Costa, Luis, additional, Pinto, Antonio Moreira, additional, Barroso, Sergio, additional, Santo, Jorge Espirito, additional, Guedes, Fátima, additional, Monteiro, Amélia, additional, Sa, Anabela, additional, Furtado, Irene, additional, Salazar, Ramon, additional, Aguilar, Enrique Aranda, additional, Herrero, Fernando Rivera, additional, Valera, Javier Sastre, additional, Ayerbes, Manuel Valladares, additional, Batlle, Jaime Feliu, additional, Gil, Silvia, additional, Esteve, Albert Abad, additional, Garcia-Giron, Carlos, additional, Vivanco, Guillermo Lopez, additional, Salvia, Antonia Salud, additional, Orduña, Vicente Alonso, additional, Garcia, Ruth Vera, additional, Gallego, Javier, additional, Sureda, Bartomeu Massuti, additional, Remon, Jordi, additional, Safont Aguilera, Maria Jose, additional, Nogueras, Luis Cirera, additional, Merino, Bernado Queralt, additional, Castro, Cristina Gravalos, additional, de Prado, Purificacion Martinez, additional, Pericay, Carlos Pijaume, additional, Figueiras, Manuel Constenla, additional, Jordan, Inmaculada Guasch, additional, Gome Reina, Maria Jose, additional, Garcia, Amelia Lopez-Ladron, additional, Garcia-Ramos, Antonio Arrivi, additional, Cervantes, Andres, additional, Martos, Carlos Fernandez, additional, Gaspar, Eugenio Marcuello, additional, Montero, Ines Cabezas, additional, Emperador, Pilar Escudero, additional, Carbonero, Ana Leon, additional, Castillo, Manuel Gallen, additional, Garcia, Teresa Garcia, additional, Lopez, Jose Garcia, additional, Flores, Encarnacion Gonzalez, additional, Morales, Monica Guillot, additional, Muñoz, Marta Llanos, additional, Martín, Ana López, additional, Maurel, Joan, additional, Camara, Juan Carlos, additional, Garcia, Rosario Dueñas, additional, Salgado, Mercedes, additional, Busquier, Isabel Hernandez, additional, Ruiz, Teresa Checa, additional, Muñoa, Adelaida Lacasta, additional, Aliguer, Miquel Nogue, additional, de Taranco, Amalia Velasco Ortiz, additional, Ureña, Miguel Mendez, additional, Gaspa, Ferran Losa, additional, Ponce, Jose Juan, additional, Roig, Carlos Bosch, additional, Jimenez, Pedro Valero, additional, Brotons, Antonio Galan, additional, Rodriguez, Santiago Albiol, additional, Martinez, Jose Ales, additional, Ruiz, Liliana Canosa, additional, Ruiz, Margarita Centelles, additional, Bridgewater, John, additional, Glynne-Jones, Rob, additional, Tahir, Saad, additional, Hickish, Tamas, additional, Cassidy, Jim, additional, and Samuel, Leslie, additional

Published
2017
Full Text
View/download PDF

39. Durable Overall Survival Benefit in Patients ≥ 60 Years with Relapsed or Refractory AML Treated with Vosaroxin/Cytarabine Vs Placebo/Cytarabine: Updated Results from the Valor Trial

Author

Ravandi, Farhad, primary, Ritchie, Ellen K., additional, Sayar, Hamid, additional, Lancet, Jeffrey E., additional, Craig, Michael, additional, Vey, Norbert, additional, Strickland, Stephen A., additional, Schiller, Gary J., additional, Jabbour, Elias J., additional, Erba, Harry P., additional, Pigneux, Arnaud, additional, Horst, Heinz-August, additional, Recher, Christian, additional, Klimek, Virginia M., additional, Cortes, Jorge E., additional, Roboz, Gail J., additional, Craig, Adam R., additional, Ward, Renee, additional, Smith, Jennifer, additional, Kantarjian, Hagop M., additional, and Stuart, Robert K., additional

Published
2016
Full Text
View/download PDF

40. Impact of Age and Midostaurin-Dose on Response and Outcome in Acute Myeloid Leukemia with FLT3-ITD: Interim-Analyses of the AMLSG 16-10 Trial

Author

Schlenk, Richard F., primary, Fiedler, Walter, additional, Salih, Helmut R., additional, Wulf, Gerald, additional, Thol, Felicitas, additional, Kündgen, Andrea, additional, Kindler, Thomas, additional, Salwender, Hans-Juergen, additional, Lübbert, Michael, additional, Brossart, Peter, additional, Westermann, Jörg, additional, Kraemer, Doris, additional, Goetze, Katharina, additional, Horst, Heinz-August, additional, Krauter, Jürgen, additional, Girschikofsky, Michael, additional, Ringhoffer, Mark, additional, Südhoff, Thomas, additional, Held, Gerhard, additional, Kirchner, Hartmut H., additional, Schmiegel, Wolff, additional, Greil, Richard, additional, Griesshammer, Martin, additional, Lange, Elisabeth, additional, Martens, Uwe, additional, Hertenstein, Bernd, additional, de Wit, Maike, additional, Koller, Elisabeth, additional, Petzer, Andreas L., additional, Hesse, Tanja, additional, Runde, Volker, additional, Reimer, Peter, additional, Schultheis, Beate S., additional, Kirchen, Heinz, additional, Griesinger, Frank, additional, Hebart, Holger, additional, Heil, Gerhard, additional, Kremers, Stephan, additional, Nachbaur, David, additional, Basara, Nadezda, additional, Schwänen, Carsten, additional, Schöndube, Daniel, additional, Greiner, Jochen, additional, Münnich, Anja, additional, Weber, Daniela, additional, Gaidzik, Verena I., additional, Teleanu, Maria-Veronica, additional, Paschka, Peter, additional, Theis, Frauke, additional, Benner, Axel, additional, Heuser, Michael, additional, Döhner, Konstanze, additional, Ganser, Arnold, additional, and Döhner, Hartmut, additional

Published
2016
Full Text
View/download PDF

41. From pills to patients: an evaluation of data sources to determine the number of people living with HIV who are receiving antiretroviral therapy in Germany

Author

Schmidt, Daniel, Kollan, Christian, Stoll, Matthias, Stellbrink, Hans-Jürgen, Plettenberg, Andreas, Fätkenheuer, Gerd, Bergmann, Frank, Bogner, Johannes R., Lunzen, Jan van, Rockstroh, Jürgen, Esser, Stefan, Jensen, Björn-Erik Ole, Horst, Heinz-August, Fritzsche, Carlos, Kühne, Andrea, Heiden, Matthias an der, Hamouda, Osamah, Bartmeyer, Barbara, and ClinSurv Study Group

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Databases, Factual, Anti-HIV Agents, Medizin, Pharmacy, HIV Infections, Composition of ART regimen, 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit, Cohort Studies, Germany, Epidemiology, medicine, Prevalence, Humans, HIV treatment, Medical prescription, Pharmacies, business.industry, Public health, Public Health, Environmental and Occupational Health, Antiretroviral drug classes, virus diseases, Middle Aged, Health market research, Pill, Cohort, Female, Biostatistics, business, Cohort study, Research Article
Abstract

Background This study aimed to determine the number of people living with HIV receiving antiretroviral therapy (ART) between 2006 and 2013 in Germany by using the available numbers of antiretroviral drug prescriptions and treatment data from the ClinSurv HIV cohort (CSH). Methods The CSH is a multi-centre, open, long-term observational cohort study with an average number of 10.400 patients in the study period 2006–2013. ART has been documented on average for 86% of those CSH patients and medication history is well documented in the CSH. The antiretroviral prescription data (APD) are reported by billing centres for pharmacies covering >99% of nationwide pharmacy sales of all individuals with statutory health insurance (SHI) in Germany (~85%). Exactly one thiacytidine-containing medication (TCM) with either emtricitabine or lamivudine is present in all antiretroviral fixed-dose combinations (FDCs). Thus, each daily dose of TCM documented in the APD is presumed to be representative of one person per day receiving ART. The proportion of non-TCM regimen days in the CSH was used to determine the corresponding number of individuals in the APD. Results The proportion of CSH patients receiving TCMs increased continuously over time (from 85% to 93%; 2006–2013). In contrast, treatment interruptions declined remarkably (from 11% to 2%; 2006–2013). The total number of HIV-infected people with ART experience in Germany increased from 31,500 (95% CI 31,000-32,000) individuals to 54,000 (95% CI 53,000-55,500) over the observation period (including 16.3% without SHI and persons who had interrupted ART). An average increase of approximately 2,900 persons receiving ART was observed annually in Germany. Conclusions A substantial increase in the number of people receiving ART was observed from 2006 to 2013 in Germany. Currently, the majority (93%) of antiretroviral regimens in the CSH included TCMs with ongoing use of FDCs. Based on these results, the future number of people receiving ART could be estimated by exclusively using TCM prescriptions, assuming that treatment guidelines will not change with respect to TCM use in ART regimens.

Published
2015

42. All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia : results of the randomized AMLSG 07-04 study

Author

German-Austrian Acute Myeloid Leukemia Study Group, Schlenk, Richard Friedrich, Lübbert, Michael, Benner, Axel, Lamparter, Alexander, Krauter, Jürgen, Herr, Wolfgang, Martin, Hans, Salih, Helmut Rainer, Kündgen, Andrea, Horst, Heinz August, Brossart, Peter, Götze, Katharina, Nachbaur, David, Wattad, Mohammed, Köhne, Claus-Henning, Fiedler, Walter, Bentz, Martin, Wulf, Gerald, Held, Gerhard, Hertenstein, Bernd, Salwender, Hans, Gaidzik, Verena I., Schlegelberger, Brigitte, Weber, Daniela, Döhner, Konstanze, Ganser, Arnold, Döhner, Hartmut, German-Austrian Acute Myeloid Leukemia Study Group, Schlenk, Richard Friedrich, Lübbert, Michael, Benner, Axel, Lamparter, Alexander, Krauter, Jürgen, Herr, Wolfgang, Martin, Hans, Salih, Helmut Rainer, Kündgen, Andrea, Horst, Heinz August, Brossart, Peter, Götze, Katharina, Nachbaur, David, Wattad, Mohammed, Köhne, Claus-Henning, Fiedler, Walter, Bentz, Martin, Wulf, Gerald, Held, Gerhard, Hertenstein, Bernd, Salwender, Hans, Gaidzik, Verena I., Schlegelberger, Brigitte, Weber, Daniela, Döhner, Konstanze, Ganser, Arnold, and Döhner, Hartmut

Abstract

The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m2, days 6-8; 15 mg/m2, days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).

Published
2016

43. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study.

Author

UCL - SSS/DDUV - Institut de Duve, UCL - (SLuc) Service d'hématologie, Ravandi, Farhad, Ritchie, Ellen K, Sayar, Hamid, Lancet, Jeffrey E, Craig, Michael D, Vey, Norbert, Strickland, Stephen A, Schiller, Gary J, Jabbour, Elias, Erba, Harry P, Pigneux, Arnaud, Horst, Heinz-August, Recher, Christian, Klimek, Virginia M, Cortes, Jorge, Roboz, Gail J, Odenike, Olatoyosi, Thomas, Xavier, Havelange, Violaine, Maertens, Johan, Derigs, Hans-Günter, Heuser, Michael, Damon, Lloyd, Powell, Bayard L, Gaidano, Gianluca, Carella, Angelo-Michele, Wei, Andrew, Hogge, Donna, Craig, Adam R, Fox, Judith A, Ward, Renee, Smith, Jennifer A, Acton, Gary, Mehta, Cyrus, Stuart, Robert K, Kantarjian, Hagop M, UCL - SSS/DDUV - Institut de Duve, UCL - (SLuc) Service d'hématologie, Ravandi, Farhad, Ritchie, Ellen K, Sayar, Hamid, Lancet, Jeffrey E, Craig, Michael D, Vey, Norbert, Strickland, Stephen A, Schiller, Gary J, Jabbour, Elias, Erba, Harry P, Pigneux, Arnaud, Horst, Heinz-August, Recher, Christian, Klimek, Virginia M, Cortes, Jorge, Roboz, Gail J, Odenike, Olatoyosi, Thomas, Xavier, Havelange, Violaine, Maertens, Johan, Derigs, Hans-Günter, Heuser, Michael, Damon, Lloyd, Powell, Bayard L, Gaidano, Gianluca, Carella, Angelo-Michele, Wei, Andrew, Hogge, Donna, Craig, Adam R, Fox, Judith A, Ward, Renee, Smith, Jennifer A, Acton, Gary, Mehta, Cyrus, Stuart, Robert K, and Kantarjian, Hagop M

Abstract

BACKGROUND: Safe and effective treatments are urgently needed for patients with relapsed or refractory acute myeloid leukaemia. We investigated the efficacy and safety of vosaroxin, a first-in-class anticancer quinolone derivative, plus cytarabine in patients with relapsed or refractory acute myeloid leukaemia. METHODS: This phase 3, double-blind, placebo-controlled trial was undertaken at 101 international sites. Eligible patients with acute myeloid leukaemia were aged 18 years of age or older and had refractory disease or were in first relapse after one or two cycles of previous induction chemotherapy, including at least one cycle of anthracycline (or anthracenedione) plus cytarabine. Patients were randomly assigned 1:1 to vosaroxin (90 mg/m(2) intravenously on days 1 and 4 in a first cycle; 70 mg/m(2) in subsequent cycles) plus cytarabine (1 g/m(2) intravenously on days 1-5) or placebo plus cytarabine through a central interactive voice system with a permuted block procedure stratified by disease status, age, and geographical location. All participants were masked to treatment assignment. The primary efficacy endpoint was overall survival and the primary safety endpoint was 30-day and 60-day all-cause mortality. Efficacy analyses were done by intention to treat; safety analyses included all treated patients. This study is registered with ClinicalTrials.gov, number NCT01191801. FINDINGS: Between Dec 17, 2010, and Sept 25, 2013, 711 patients were randomly assigned to vosaroxin plus cytarabine (n=356) or placebo plus cytarabine (n=355). At the final analysis, median overall survival was 7·5 months (95% CI 6·4-8·5) in the vosaroxin plus cytarabine group and 6·1 months (5·2-7·1) in the placebo plus cytarabine group (hazard ratio 0·87, 95% CI 0·73-1·02; unstratified log-rank p=0·061; stratified p=0·024). A higher proportion of patients achieved complete remission in the vosaroxin plus cytarabine group than in the placebo plus cytarabine group (107 [30%] of 356 patients

Published
2015

44. Midostaurin in Combination with Intensive Induction and As Single Agent Maintenance Therapy after Consolidation Therapy with Allogeneic Hematopoietic Stem Cell Transplantation or High-Dose Cytarabine (NCT01477606)

Author

Schlenk, Richard, primary, Döhner, Konstanze, additional, Salih, Helmut, additional, Kündgen, Andrea, additional, Fiedler, Walter, additional, Salwender, Hans-Juergen, additional, Westermann, Joerg, additional, Götze, Katharina S., additional, Horst, Heinz-August, additional, Wulf, Gerald, additional, Lübbert, Michael, additional, Kraemer, Doris, additional, Kindler, Thomas, additional, Ringhoffer, Mark, additional, Brossart, Peter, additional, Held, Gerhard, additional, Greil, Richard, additional, Südhoff, Thomas, additional, Münnich, Anja, additional, Weber, Daniela, additional, Gaidzik, Verena I., additional, Teleanu, Maria-Veronica, additional, Paschka, Peter, additional, Theis, Frauke, additional, Heuser, Michael, additional, Thol, Felicitas, additional, Benner, Axel, additional, Ganser, Arnold, additional, and Döhner, Hartmut, additional

Published
2015
Full Text
View/download PDF

45. Baseline Predictors of Mortality in Patients with Relapsed or Refractory Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine in the Phase 3 VALOR Study

Author

Lancet, Jeffrey E, primary, Ravandi, Farhad, additional, Ritchie, Ellen K, additional, Sayar, Hamid, additional, Strickland, Stephen A., additional, Schiller, Gary J, additional, Vey, Norbert, additional, Erba, Harry P, additional, Pigneux, Arnaud, additional, Horst, Heinz-August, additional, Recher, Christian, additional, Odenike, Olatoyosi, additional, Carella, Angelo-Michele, additional, Selleslag, Dominik, additional, Kell, Jonathan, additional, Krug, Utz, additional, Page, Leigh, additional, DeVault, Art, additional, Hwang, Shuling, additional, Craig, Adam R, additional, and Stuart, Robert K., additional

Published
2015
Full Text
View/download PDF

46. Pharmacodynamic Monitoring of the Efficacy of a Targeted Therapy with Midostaurin By Plasma Inhibitor Activity (PIA) Analysis in FLT3 -ITD Positive AML Patients within the AMLSG 16-10 Trial: A Study of the AML Study Group (AMLSG)

Author

Theis, Frauke, primary, Paschka, Peter, additional, Weber, Daniela, additional, Gaidzik, Verena I., additional, Bullinger, Lars, additional, Teleanu, Maria-Veronica, additional, Göhring, Gudrun, additional, Salih, Helmut R., additional, Kündgen, Andrea, additional, Salwender, Hans-Juergen, additional, Westermann, Joerg, additional, Fiedler, Walter, additional, Götze, Katharina, additional, Horst, Heinz-August, additional, Wulf, Gerald G, additional, Luebbert, Michael, additional, Wolf, Dominik, additional, Kindler, Thomas, additional, Ringhoffer, Mark, additional, Kraemer, Doris, additional, Krauter, Jürgen, additional, Thol, Felicitas, additional, Heuser, Michael, additional, Ganser, Arnold, additional, Döhner, Hartmut, additional, Schlenk, Richard F., additional, and Döhner, Konstanze, additional

Published
2015
Full Text
View/download PDF

48. Sequential treatment with rituximab followed by CHOP chemotherapy in adult B-cell post-transplant lymphoproliferative disorder (PTLD): the prospective international multicentre phase 2 PTLD-1 trial

Author

Trappe, Ralf, Oertel, Stephan, Leblond, Veronique, Mollee, Peter, Sender, Monica, Reinke, Petra, Neuhaus, Ruth, Lehmkuhl, Hans, Horst, Heinz August, Salles, Gilles, Morschhauser, Franck, Jaccard, Arnaud, Lamy, Thierry, Leithäuser, Malte, Zimmermann, Heiner, Anagnostopoulos, Ioannis, Raphael, Martine, Riess, Hanno, Choquet, Sylvain, Renseigné, Non, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Service d'hématologie, Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Contrôle de la Réponse Immune B et des Lymphoproliférations (CRIBL), Université de Limoges (UNILIM)-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Centre National de la Recherche Scientifique (CNRS), Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges], and CHU Limoges

Subjects
Male, Epstein-Barr Virus Infections, Herpesvirus 4, Human, medicine.medical_treatment, MESH: Antigens, CD20, CHOP, Antibodies, Monoclonal, Murine-Derived, 0302 clinical medicine, MESH: Lymphoproliferative Disorders, hemic and lymphatic diseases, Germany, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Prospective Studies, MESH: Aged, MESH: Middle Aged, MESH: Epstein-Barr Virus Infections, Middle Aged, 3. Good health, MESH: Antineoplastic Combined Chemotherapy Protocols, Oncology, Vincristine, 030220 oncology & carcinogenesis, Prednisolone, [SDV.IMM]Life Sciences [q-bio]/Immunology, Rituximab, Female, France, medicine.drug, Adult, medicine.medical_specialty, Cyclophosphamide, Adolescent, MESH: Organ Transplantation, MESH: Vincristine, Post-transplant lymphoproliferative disorder, 03 medical and health sciences, MESH: Doxorubicin, Internal medicine, medicine, Humans, MESH: Germany, Aged, MESH: Adolescent, Chemotherapy, MESH: Humans, business.industry, MESH: Cyclophosphamide, MESH: Adult, MESH: Herpesvirus 4, Human, Organ Transplantation, medicine.disease, Antigens, CD20, MESH: Male, MESH: Prospective Studies, Lymphoproliferative Disorders, Surgery, MESH: France, MESH: Antibodies, Monoclonal, Murine-Derived, Doxorubicin, business, MESH: Prednisolone, MESH: Female, 030215 immunology
Abstract

International audience; BACKGROUND: Post-transplantation lymphoproliferative disorder (PTLD) develops in 1-10% of transplant recipients and can be Epstein-Barr virus (EBV) associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxic effects of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) chemotherapy seen in first-line treatment, we initiated a phase 2 trial to test whether the subsequent use of rituximab and CHOP would improve the outcome of patients with PTLD. METHODS: In this international multicentre open-label phase 2 trial, treatment-naive adult solid-organ transplant recipients diagnosed with CD20-positive PTLD who had failed to respond to upfront immunosuppression reduction received four courses of rituximab (375 mg/m(2) intravenously) once a week followed by 4 weeks without treatment and four cycles of CHOP every 3 weeks. In case of disease progression during rituximab monotherapy, CHOP was started immediately. Supportive therapy with granulocyte-colony stimulating factor after chemotherapy was mandatory and antibiotic prophylaxis was recommended. The primary endpoint was treatment efficacy measured as response rates in all patients who completed treatment with rituximab and CHOP, per protocol, and response duration, in all patients who completed all planned therapy and responded. Secondary endpoints were frequency of infections, treatment-related mortality, and overall survival. This study is registered at ClinicalTrials.gov, number NCT01458548. FINDINGS: 74 patients were enrolled between Dec 12, 2002 and May 5, 2008, of whom 70 patients were eligible to receive treatment. PTLD was of late type in 53 (76%) of 70 patients, monomorphic in 67 (96%) of 70, and histologically EBV associated in 29 (44%) of 66 cases. Four of 70 patients did not receive CHOP. 53 of 59 patients had a complete or partial response (90%, 95% CI 79-96), of which 40 (68%, 55-78) were complete responses. At data cutoff (June 1, 2011) median response duration in the 53 patients who had responded to treatment had not yet been reached (>79*1 months). The main adverse events were grade 3-4 leucopenia in 42 of 62 patients (68%, 55-78) and infections of grade 3-4 in 26 of 64 patients (41%, 29-53). Seven of 66 patients (11%, 5-21) had CHOP-associated treatment-related mortality. Median overall survival was 6*6 years (95% CI 2*8-10*4; n=70). INTERPRETATION: Our results support the use of sequential immunochemotherapy with rituximab and CHOP in PTLD. FUNDING: F Hoffmann-La Roche, Amgen Germany, Chugaï France.

Published
2011
Full Text
View/download PDF

49. Phase III Open-Label Randomized Study of Cytarabine in Combination With Amonafide L-Malate or Daunorubicin As Induction Therapy for Patients With Secondary Acute Myeloid Leukemia

Author

Stone, Richard M., primary, Mazzola, Emanuele, additional, Neuberg, Donna, additional, Allen, Steven L., additional, Pigneux, Arnaud, additional, Stuart, Robert K., additional, Wetzler, Meir, additional, Rizzieri, David, additional, Erba, Harry P., additional, Damon, Lloyd, additional, Jang, Jun-Ho, additional, Tallman, Martin S., additional, Warzocha, Krzysztof, additional, Masszi, Tamás, additional, Sekeres, Mikkael A., additional, Egyed, Miklos, additional, Horst, Heinz-August, additional, Selleslag, Dominik, additional, Solomon, Scott R., additional, Venugopal, Parameswaran, additional, Lundberg, Ante S., additional, and Powell, Bayard, additional

Published
2015
Full Text
View/download PDF

50. Prognostic value of KRAS mutations in stage III colon cancer: post hoc analysis of the PETACC8 phase III trial dataset

Author

Thaler, Josef, primary, Greil, Richard, additional, Gaenzer, Johannes, additional, Eisterer, Wolfgang, additional, Tschmelitsch, Joerg, additional, Samonigg, Hellmut, additional, Zabernigg, August, additional, Schmid, Franz, additional, Steger, Günther, additional, Steinacher, Robert, additional, Andel, Johannes, additional, Lang, Alois, additional, Függer, Reinhold, additional, Hofbauer, Friedrich, additional, Woell, Ewald, additional, Geissler, Dietmar, additional, Lenauer, Alfred, additional, Prager, Manfred, additional, Van Laethem, Jean-Luc, additional, Van Cutsem, Eric, additional, D'Haens, Geert, additional, Demolin, Gauthier, additional, Kerger, Joseph, additional, Deboever, Guido, additional, Ghillebert, Gilbert, additional, Polus, Marc, additional, RezaieKalantari, Hassan, additional, Delaunoit, Thierry, additional, Goeminne, Jean Charles, additional, Peeters, Marc, additional, Vergauwe, Philippe, additional, Houbiers, Ghislain, additional, Humblet, Yves, additional, Janssens, Jos, additional, Schrijvers, Dirk, additional, Vanderstraeten, Erik, additional, Vermorken, Jan, additional, Van Daele, Daniel, additional, Ferrante, Michel, additional, Forget, Frederic, additional, Hendlisz, Alain, additional, Yilmaz, Mette, additional, Nielsen, Svend Erik, additional, Vestermark, Lene, additional, Larsen, Jim, additional, Ychou, Marc, additional, Zawadi, Ayman, additional, Zawadi, Mohamed-Ayman, additional, Bouche, Olivier, additional, Mineur, Laurent, additional, Bennouna-Louridi, Jaafar, additional, Dourthe, Louis Marie, additional, Boucher, Eveline, additional, Taieb, Julien, additional, Pezet, Denis, additional, Desseigne, Francoise, additional, Ducreux, Michel, additional, Texereau, Patrick, additional, Miglianico, Laurent, additional, Rougier, Philippe, additional, Fratte, Serge, additional, Levache, Charles-Briac, additional, Merrouche,, Yacine, additional, Ellis, Stephen, additional, Locher, Christophe, additional, Ramee, Jean-Francois, additional, Garnier, Claire, additional, Viret, Frederic, additional, Chauffert, Bruno, additional, Cojean-Zelek, Isabelle, additional, Michel, Pierre, additional, Lecaille, Cedric, additional, Borel, Christian, additional, Seitz, Jean-Francois, additional, Smith, Denis, additional, Lombard-Bohas, Catherine, additional, Andre, Thierry, additional, Gornet, Jean-Marc, additional, Fein, Francine, additional, Coulon-Sfairi, Marie-Aude, additional, Kaminsky, Marie-Christine, additional, Lagasse, Jean-Paul, additional, Luet, Dominique, additional, Etienne, Pierre-Luc, additional, Gasmi, Mohamed, additional, Vanoli, Andre, additional, Nguyen, Suzanne, additional, Aparicio, Thomas, additional, Perrier, Hervé, additional, Stremsdoerfer, Noel, additional, Laplaige, Philippe, additional, Arsene, Dominique, additional, Auby, Dominique, additional, Bedenne, Laurent, additional, Coriat, Romain, additional, Denis, Bernard, additional, Geoffroy, Patrick, additional, Piot, Gilles, additional, Becouarn, Yves, additional, Bordes, Gilbert, additional, Deplanque, Gael, additional, Dupuis, Olivier, additional, Fruge, Frederic, additional, Guimbaud, Rosine, additional, Lecomte, Thierry, additional, Lledo, Gérard, additional, Sobhani, Iradej, additional, Asnacios, Amani, additional, Azzedine, Ahmed, additional, Desauw, Christophe, additional, Galais, Marie-Pierre, additional, Gargot, Dany, additional, Lam, You-Heng, additional, Abakar-Mahamat, Abakar, additional, Berdah, Jean-Francois, additional, Catteau, Sylviane, additional, Clavero-Fabri, Marie-Christine, additional, Codoul, Jean-Francois, additional, Legoux, Jean-Louis, additional, Goldfain, Denis, additional, Guichard, Pierre, additional, Verge, Denis Pere, additional, Provencal, Jocelyne, additional, Vedrenne, Bruno, additional, Brezault-Bonnet, Catherine, additional, Cleau, Denis, additional, Desir, Jean-Paul, additional, Fallik, David, additional, Garcia, Bruno, additional, Gaspard, Marie-Hélène, additional, Genet, Dominique, additional, Hartwig, Johannes, additional, Krummel, Yves, additional, MatysiakBudnik, Tamara, additional, Palascak-Juif, Vanessa, additional, Randrianarivelo, Harizo, additional, Rinaldi, Yves, additional, Aleba, Albert, additional, Darut-Jouve, Ariane, additional, de Gramont, Aimery, additional, Hamon, Herve, additional, Wendehenne, Frederic, additional, Matzdorff, Axel, additional, Stahl, Michael Konrad, additional, Schepp, Wolfgang, additional, Burk, Martin, additional, Mueller, Lothar, additional, Folprecht, Gunnar, additional, Geissler, Michael, additional, Mantovani-Loeffler, Luisa, additional, Hoehler, Thomas, additional, Asperger, Walter, additional, Kroening, Hendrik, additional, von Weikersthal, Ludwig Fischer, additional, Fuxius, Stefan, additional, Groschek, Matthias, additional, Meiler, Johannes, additional, Trarbach, Tanja, additional, Rauh, Jacqueline, additional, Ziegenhagen, Nicolas, additional, Kretzschmar, Albrecht, additional, Graeven, Ullrich, additional, Nusch, Arnd, additional, von Wichert, Goetz, additional, Hofheinz, Ralf-Dieter, additional, Kleber, Gerhard, additional, Schmidt, Karl-Heinz, additional, Vehling-Kaiser, Ursula, additional, Baum, Claudia, additional, Schuette, Jochen, additional, Haag, Georg Martin, additional, Holtkamp, Wilhelm, additional, Potenberg, Jochen, additional, Reiber, Tobias, additional, Schliesser, Georg, additional, Schmoll, Hans-Joachim, additional, Schneider-Kappus, Wolfgang, additional, Abenhardt, Wolfgang, additional, Denzlinger, Claudio, additional, Henning, Jan, additional, Marxsen, Bartscht, additional, GuenterDerigs, Hans, additional, Lambertz, Helmut, additional, Becker-Boost, Ingulf, additional, Caca, Karel, additional, Constantin, Christian, additional, Decker, Thomas, additional, Eschenburg, Henning, additional, Gabius, Sigrun, additional, Hebart, Holger, additional, Hoffmeister, Albrecht, additional, Horst, Heinz-August, additional, Kremers, Stephan, additional, Leithaeuser, Malte, additional, Mueller, Sebastian, additional, Wagner, Siegfried, additional, Daum, Severin, additional, Schlegel, Frank, additional, Stauch, Martina, additional, Heinemann, Volker, additional, Labianca, Roberto, additional, Colucci, Giuseppe, additional, Amadori, Dino, additional, Mini, Enrico, additional, Falcone, Alfredo, additional, Boni, Corrado, additional, Maiello, Evaristo, additional, Latini, Luciano, additional, Zaniboni, Alberto, additional, Aprile, Giuseppe, additional, Barni, Sandro, additional, Mattioli, Rodolfo, additional, Martoni, Andrea, additional, Passalacqua, Rodolfo, additional, Nicolini, Mario, additional, Pasquini, Enzo, additional, Rabbi, Carla, additional, Aitini, Enrico, additional, Ravaioli, Alberto, additional, Barone, Carlo, additional, Biasco, Guido, additional, Tamberi, Stefano, additional, Gambi, Angelo, additional, Verusio, Claudio, additional, Marzola, Marina, additional, Lelli, Giorgio, additional, Cascinu, Stefano, additional, Bidoli, Paolo, additional, Vaghi, Massimo, additional, Cruciani, Giorgio, additional, Di Costanzo, Francesco, additional, Sobrero, Alberto, additional, Petrioli, Roberto, additional, Aglietta, Massimo, additional, Alabiso, Oscar, additional, Capuzzo, Federico, additional, Corsi, Domenico Cristi, additional, Salvagni, Stefania, additional, Chiara, Silvana, additional, Ferraù, Francesco, additional, Giuliani, Francesco, additional, Lonardi, Sara, additional, Gebbia, Nicola, additional, Mantovani, Giovanni, additional, Sanches, Evaristo, additional, Mellidez, Juan Carlos, additional, Santos, Pedro, additional, Freire, Joao, additional, Sarmento, Cristina, additional, Costa, Luis, additional, Pinto, Antonio Moreira, additional, Barroso, Sergio, additional, Santo, Jorge Espirito, additional, Guedes, Fátima, additional, Monteiro, Amélia, additional, Sa, Anabela, additional, Furtado, Irene, additional, Tabernero, Josep, additional, Salazar, Ramon, additional, Aguilar, Enrique Aranda, additional, Herrero, Fernando Rivera, additional, Valera, Javier Sastre, additional, ValladaresAyerbes, Manuel, additional, FeliuBatlle, Jaime, additional, Gil, Silvia, additional, Garcia-Giron, Carlos, additional, Vivanco, Guillermo Lopez, additional, Salvia, Antonia Salud, additional, Orduña, Vicente Alonso, additional, Garcia, Ruth Vera, additional, Gallego, Javier, additional, Sureda, Bartomeu Massuti, additional, Remon, Jordi, additional, Safont Aguilera, Maria Jose, additional, CireraNogueras, Luis, additional, Merino, BernadoQueralt, additional, Castro, Cristina Gravalos, additional, de Prado, Purificacion Martinez, additional, PijaumePericay, Carlos, additional, ConstenlaFigueiras, Manuel, additional, Jordan, InmaculadaGuasch, additional, GomeReina, Maria Jose, additional, Garcia, Amelia Lopez-Ladron, additional, Garcia-Ramos, Antonio Arrivi, additional, Cervantes, Andres, additional, Martos, Carlos Fernandez, additional, MarcuelloGaspar, Eugenio, additional, Montero, Ines Cabezas, additional, Emperador, Pilar Escudero, additional, Carbonero, Ana Leon, additional, Castillo, Manuel Gallen, additional, Garcia, Teresa Garcia, additional, Lopez, Jose Garcia, additional, Flores, Encarnacion Gonzalez, additional, GuillotMorales, Monica, additional, LlanosMuñoz, Marta, additional, Martín, Ana López, additional, Maurel, Joan, additional, Camara, Juan Carlos, additional, Garcia, Rosario Dueñas, additional, Salgado, Mercedes, additional, HernandezBusquier, Isabel, additional, Ruiz, Teresa Checa, additional, LacastaMuñoa, Adelaida, additional, Aliguer, MiquelNogue, additional, Ortiz de Taranco, Amalia Velasco, additional, Ureña, Miguel Mendez, additional, Gaspa, Ferran Losa, additional, Ponce, Jose Juan, additional, Roig, Carlos Bosch, additional, Jimenez, Pedro Valero, additional, GalanBrotons, Antonio, additional, AlbiolRodriguez, Santiago, additional, Martinez, Jose Ales, additional, Ruiz, Liliana Canosa, additional, CentellesRuiz, Margarita, additional, Bridgewater, John, additional, Glynne-Jones, Rob, additional, Tahir, Saad, additional, Hickish, Tamas, additional, Cassidy, Jim, additional, and Samuel, Leslie, additional

Published
2015
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results