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5 results on '"Lepretre, Stephane"'

1. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial

Author

Byrd, John C, Hillmen, Peter, Ghia, Paolo, Kater, Arnon P, Chanan-Khan, Asher, Furman, Richard R, O'Brien, Susan, Yenerel, Mustafa Nuri, Illés, Arpad, Kay, Neil, Garcia-Marco, Jose A, Mato, Anthony, Pinilla-Ibarz, Javier, Seymour, John F, Lepretre, Stephane, Stilgenbauer, Stephan, Robak, Tadeusz, Rothbaum, Wayne, Izumi, Raquel, Hamdy, Ahmed, Patel, Priti, Higgins, Kara, Sohoni, Sophia, and Jurczak, Wojciech

Subjects
Clinical Research, Hematology, Lymphoma, Cancer, Rare Diseases, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adenine, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Benzamides, Female, Follow-Up Studies, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Piperidines, Prognosis, Prospective Studies, Pyrazines, Survival Rate, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeAmong Bruton's tyrosine kinase inhibitors, acalabrutinib has greater selectivity than ibrutinib, which we hypothesized would improve continuous therapy tolerability. We conducted an open-label, randomized, noninferiority, phase III trial comparing acalabrutinib and ibrutinib in patients with chronic lymphocytic leukemia (CLL).MethodsPatients with previously treated CLL with centrally confirmed del(17)(p13.1) or del(11)(q22.3) were randomly assigned to oral acalabrutinib 100 mg twice daily or ibrutinib 420 mg once daily until progression or unacceptable toxicity. The primary end point was independent review committee-assessed noninferiority of progression-free survival (PFS).ResultsOverall, 533 patients (acalabrutinib, n = 268; ibrutinib, n = 265) were randomly assigned. At the data cutoff, 124 (46.3%) acalabrutinib patients and 109 (41.1%) ibrutinib patients remained on treatment. After a median follow-up of 40.9 months, acalabrutinib was determined to be noninferior to ibrutinib with a median PFS of 38.4 months in both arms (95% CI acalabrutinib, 33.0 to 38.6 and ibrutinib, 33.0 to 41.6; hazard ratio: 1.00; 95% CI, 0.79 to 1.27). All-grade atrial fibrillation/atrial flutter incidence was significantly lower with acalabrutinib versus ibrutinib (9.4% v 16.0%; P = .02); among other selected secondary end points, grade 3 or higher infections (30.8% v 30.0%) and Richter transformations (3.8% v 4.9%) were comparable between groups and median overall survival was not reached in either arm (hazard ratio, 0.82; 95% CI, 0.59 to 1.15), with 63 (23.5%) deaths with acalabrutinib and 73 (27.5%) with ibrutinib. Treatment discontinuations because of adverse events occurred in 14.7% of acalabrutinib-treated patients and 21.3% of ibrutinib-treated patients.ConclusionIn this first direct comparison of less versus more selective Bruton's tyrosine kinase inhibitors in CLL, acalabrutinib demonstrated noninferior PFS with fewer cardiovascular adverse events.

Published
2021

2. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.

Author

Kreitman, Robert, Dearden, Claire, Zinzani, Pier, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas, le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjorn, Gobbi, Marco, Hellmann, Andrzej, Lepretre, Stephane, Maloisel, Frederic, Ravandi, Farhad, Rousselot, Philippe, Rummel, Mathias, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia, Saglio, Giuseppe, Roboz, Gail, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, and Giles, Francis

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Bacterial Toxins, Drug Resistance, Neoplasm, Exotoxins, Female, Follow-Up Studies, Humans, Leukemia, Hairy Cell, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Remission Induction, Salvage Therapy, Survival Rate
Abstract

This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Published
2018

3. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

Author

Awan, Farrukh T, Hillmen, Peter, Hellmann, Andrzej, Robak, Tadeusz, Hughes, Steven G., Trone, Denise, Shannon, Megan, Flinn, Ian W., Byrd, John C., Riveros, Dardo, Pavlovsky, Santiago, Iastrebner, Claudio M., Carney, Dennis A., Deveridge, Sandra, Durrant, Simon, Hahn, Uwe H., Hertzberg, Mark, Leahy, Michael F., David, Ma, Marlton, Paula, Mulligan, Stephen, Opat, Stephen S., Tiley, Campbell, Wickham, Nicholas W., Cannell, Paul, Gatalano, John, Catalano, John, Cull, Gavin, Luen B., To, Hopfinger, Georg, Jager, Ulrich, Linkesch, Werner, Petzer, Andreas, Schwarzmeier, Josef, Steurer, Michael, Greil, Richard, Bememan, Zwi, Bosly, Andre, Bron, Dominique, Janssens, Ann, Offner, Fritz, Van Den Neste, Eric W., Ka Lung, Wu, Van Hoof, Achiel, Maiolino, Angelo, Pinczowski, Helio, Zanichelli, Maria A., Pereira, Juliana, Larratt, Loree, Spaner, David, Howson Jan, Kang, Chen, Christine I., Cantin, Guy, Fernandez, Louis A., Fraser, Graeme, Mayer, Jiri, Trneny, Marek, Jebavy, Ladislav, Bordessoule, Dominique, Lamy, Thierry, Milpied, Noel, Truchan Graczyk, Malgorzata, Eghbali, Houchingue, Karsenti, Jean Michel, Celigny, Philippe Solal, Mans, Le, Cazin, Bruno, Gyan, Emmanuel, Lepretre, Stephane, Bergmann, Lothar, Tsionos, Konstantinos, Lokeshwar, Nilesh M., Agarwal, Mohan B., Ross, Cecil R., Deshmukh, Chetan D., Narayanan, Geetha, Raina, Vinod, Bondarde, Shailesh A., Shah, Bhavin A., Bairey, Osnat, Tikva, Petach, Shvidel, Lev, Ambrosetti, Achille, Rossi, Policlinico G. B., Angelucci, Emanuele, Carella, Angelo M., Massaia, Massimo, Zinzani, Pier L., Caligaris Cappio, Federico, Foa, Roberto, Gaidano, Gianluca, della Caritá, A. O. Maggiore, Leone, Giuseppe, Santoro, Armando, Griskevicius, Laimonas, Jurgutis, Romualdas, Baker, Bartrum W., Hawkins, Timothy, Corbett, Gillian M., Ganly, Peter, D'Souza, Alvyn B., Deptala, Andrzej, Holowiecki, Jerzy, Kloczko, Janusz, Skotnicki, Aleksander, Zdziarska, Barbara, Kyrcz Krzemien, Slawomira, Dmoszynska, Anna, Moreira, Anna, Pereira, Ana P., Colita, Andrei, Moicean, Andreea D., Vasilica, Mariana, Danaila, Catalin, Gheorghita, Emanuil, Pavlov, Vyacheslav V., Rossiev, Viktor A., Konstantinova, Tatiana, Samoilova, Olga S., Novgorod, Nizhniy, Shelekhova, Tatyana, Zaritsky, Andrey Y., Abdulkadyrov, Kudrat M., Zyuzgin, Ilya S., Pristupa, Alexander S., Loscertales, Javier, Vidal, Joan Besalduch, de Mallorca, Palma, Gonzalez, Marcos, Ortuno, Francisco, Giraldo, Pilar, Nathwani, Amit, Agrawal, Samir G., Rule, Simon, Dearden, Claire E., Bloor, Adrian J., Haynes, Andrew, Singer, Charles, Boclek, Robert G., Bosserman, Linda D., Chan, David, Davidson, Sheldon J., Dichmann, Robert A., Farber, Charles, Hart, Lowell, Hermann, Robert, Eddie, Hu, Janakiraman, Nalini, Jonas, William, Liem, Kiem D., Mcintyre, Rosemary E., O'Brien, Susan, Patel, Giribala, Rado, Thomas, Schilder, Russell, Smith, Scott E., Stock, Wendy, Turturro, Francesco, Venugopal, Parameswaran, Anderson, Thomas C., Berry, William, Boyd, Thomas E., Byrd, John, Cooper, Maureen, Flinn, Ian, Gersh, Robert, Gordon, David, Guzley, Gregory J., Wilks, Sharon T., Klein, Andreas, Krauss, John C., Lister, John, Mandell, Lance, Molina, Arthur, Cooper, Barry, Pendergrass, Kelly B., Reeder, Craig, Savin, Michael A., Spitzer, Gary, Tuscano, Joseph M., Vandeventer, Hendrik, Eradat, Herbert A., Masood, Aisha, Mena, Raul, F. T. Awan, P. Hillmen, A. Hellmann, T. Robak, S. G. Hughe, D. Trone, M. Shannon, I. W. Flinn, J. C. Byrd, L. U. C., and Riveros D, Iastrebner CM, Carney DA, Deveridge S, Durrant S, Hahn UH, Hertzberg M, Leahy MF, Ma D, Marlton P, Mulligan S, Opat SS, Tiley C, Wickham NW, Cannell P, Gatalano J, Cull G, B To L, Catalano J, Wickham NW, Hopfinger G, Jager U, Linkesch W, Petzer A, Schwarzmeier J, Steurer M, Greil R, Bememan Z, Bosly A, Bron D, Janssens A, Offner F, Van Den Neste EW, Wu KL, Van Hoof A, Maiolino A, Pinczowski H, Zanichelli MA, Pereira J, Larratt L, Spaner D, Howson-Jan K, Chen CI, Fernandez LA, Fraser G, Mayer J, Trneny M, Jebavy L, Bordessoule D, Lamy T, Milpied N, Eghbali H, Karsenti JM, Celigny PS, Cazin B, Gyan E, Lepretre S, Bergmann L, Tsionos K, Lokeshwar NM, Agarwal MB, Ross CR, Deshmukh CD, Narayanan G, Raina V, Bondarde SA, Shah BA, Bairey O, Ben-Yehuda D, Shvidel L, Ambrosetti A, Angelucci E, Carella AM, Massaia M, Zinzani PL, Caligaris-Cappio F, Foa R, Gaidano G, Leone G, Santoro A, Griskevicius L, Jurgutis R, Baker BW, Hawkins T, Corbett GM, Ganly P, D'Souza AB, Deptala A, Hellmann A, Holowiecki J, Kloczko J, Skotnicki A, Zdziarska B, Robak T, Dmoszynska A, Moreira I, Pereira AP, Colita A, Moicean AD, Gheorghita E, Vasilica M, Pavlov VV, Rossiev VA, Konstantinova T, Samoilova OS, Novgorod N, Shelekhova T, Zaritsky AY, Abdulkadyrov KM, Zyuzgin IS, Pristupa AS, Loscertales J, Casado LF, Gonzalez M, Ortuno F, Giraldo P, Servet M, Nathwani A, Howson-Jan K, Agrawal SG, Hillmen P, Rule S, Dearden CE, Bloor AJ, Haynes A, Singer C, Boclek RG, Bosserman LD, Chan D, Davidson SJ, Dichmann RA, Farber C, Guzley GJ, Hermann R, Hu E, Janakiraman N, Jonas W, Liem KD, Mcintyre RE, O'Brien S, Patel G, Rado T, Schilder R, Smith SE, Stock W, Turturro F, Venugopal P, Berry W, Boyd TE, Byrd J, Cooper M, Flinn I, Gersh R, Gordon D, Wilks ST, Klein A, Krauss JC, Lister J, Mandell L, Molina A, Pendergrass KB, Reeder C, Savin MA, Spitzer G, Tuscano JM, van Deventer H, Eradat HA, Cooper B, Masood A, Mena R.

Subjects
Oncology, Male, Chronic lymphocytic leukaemia, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Pharmacology, Antibodies, Monoclonal, Murine-Derived, Recurrence, hemic and lymphatic diseases, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Medicine, drug therapy, Male, Middle Aged, Recurrence, Vidarabine, Chronic, Aged, 80 and over, Leukemia, Medicine (all), Antibodies, Monoclonal, Hematology, Middle Aged, Adult, Aged, Aged, Lymphocytic, Fludarabine, Tolerability, Small lymphocytic lymphoma, administration /&/ dosage/adverse effects, Female, Humans, Leukemia, Rituximab, Female, Vidarabine, medicine.drug, Adult, Murine-Derived, medicine.medical_specialty, Cyclophosphamide, chemical and pharmacologic phenomena, CD23, Lumiliximab, Aged, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Antibodies, chronic lymphocytic leukaemia, lumiliximab, small lymphocytic lymphoma, Internal medicine, administration /&/ dosage/adverse effects/analogs /&/ derivatives, 80 and over, Antibodie, Adverse effect, Lymphocytic leukaemia, business.industry, administration /&/ dosage/adverse effects, Antibodie, B-Cell, administration /&/ dosage/adverse effects, Cyclophosphamide, Interim analysis, administration /&/ dosage/adverse effects, Antineoplastic Combined Chemotherapy Protocol, business
Abstract

Item does not contain fulltext Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.

Published
2014

4. Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia : results of the first randomized phase III trial

Author

Raquel Izumi, Ahmed Hamdy, Wayne Rothbaum, Susan O'Brien, Paolo Ghia, Peter Hillmen, Kara Higgins, Richard R. Furman, Tadeusz Robak, Wojciech Jurczak, José A. García-Marco, Arnon P. Kater, Priti Patel, Stephan Stilgenbauer, Mustafa Nuri Yenerel, John C. Byrd, Asher Chanan-Khan, Neil E. Kay, Javier Pinilla-Ibarz, Árpád Illés, Anthony R. Mato, John F. Seymour, Sophia Sohoni, Stéphane Leprêtre, Byrd, John C, Hillmen, Peter, Ghia, Paolo, Kater, Arnon P, Chanan-Khan, Asher, Furman, Richard R, O'Brien, Susan, Yenerel, Mustafa Nuri, Illés, Arpad, Kay, Neil, Garcia-Marco, Jose A, Mato, Anthony, Pinilla-Ibarz, Javier, Seymour, John F, Lepretre, Stephane, Stilgenbauer, Stephan, Robak, Tadeusz, Rothbaum, Wayne, Izumi, Raquel, Hamdy, Ahmed, Patel, Priti, Higgins, Kara, Sohoni, Sophia, Jurczak, Wojciech, AII - Cancer immunology, Experimental Immunology, Clinical Haematology, and CCA - Cancer Treatment and Quality of Life

Subjects
Adult, Male, Continuous therapy, Oncology, Cancer Research, medicine.medical_specialty, Chronic lymphocytic leukemia, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Prospective Studies, Aged, Aged, 80 and over, business.industry, Adenine, Editorials, Middle Aged, Prognosis, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, Survival Rate, Tolerability, chemistry, Pyrazines, 030220 oncology & carcinogenesis, Ibrutinib, Benzamides, Acalabrutinib, Female, business, Previously treated, Tyrosine kinase, Follow-Up Studies, 030215 immunology
Abstract

PURPOSE Among Bruton's tyrosine kinase inhibitors, acalabrutinib has greater selectivity than ibrutinib, which we hypothesized would improve continuous therapy tolerability. We conducted an open-label, randomized, noninferiority, phase III trial comparing acalabrutinib and ibrutinib in patients with chronic lymphocytic leukemia (CLL). METHODS Patients with previously treated CLL with centrally confirmed del(17)(p13.1) or del(11)(q22.3) were randomly assigned to oral acalabrutinib 100 mg twice daily or ibrutinib 420 mg once daily until progression or unacceptable toxicity. The primary end point was independent review committee–assessed noninferiority of progression-free survival (PFS). RESULTS Overall, 533 patients (acalabrutinib, n = 268; ibrutinib, n = 265) were randomly assigned. At the data cutoff, 124 (46.3%) acalabrutinib patients and 109 (41.1%) ibrutinib patients remained on treatment. After a median follow-up of 40.9 months, acalabrutinib was determined to be noninferior to ibrutinib with a median PFS of 38.4 months in both arms (95% CI acalabrutinib, 33.0 to 38.6 and ibrutinib, 33.0 to 41.6; hazard ratio: 1.00; 95% CI, 0.79 to 1.27). All-grade atrial fibrillation/atrial flutter incidence was significantly lower with acalabrutinib versus ibrutinib (9.4% v 16.0%; P = .02); among other selected secondary end points, grade 3 or higher infections (30.8% v 30.0%) and Richter transformations (3.8% v 4.9%) were comparable between groups and median overall survival was not reached in either arm (hazard ratio, 0.82; 95% CI, 0.59 to 1.15), with 63 (23.5%) deaths with acalabrutinib and 73 (27.5%) with ibrutinib. Treatment discontinuations because of adverse events occurred in 14.7% of acalabrutinib-treated patients and 21.3% of ibrutinib-treated patients. CONCLUSION In this first direct comparison of less versus more selective Bruton's tyrosine kinase inhibitors in CLL, acalabrutinib demonstrated noninferior PFS with fewer cardiovascular adverse events.

Published
2021

5. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia

Author

Philippe Rousselot, Shira Dinner, Robert J. Kreitman, Bjørn Tore Gjertsen, Monica Bocchia, Andrzej Hellmann, Lionel Karlin, Fritz Offner, Philipp le Coutre, Gary J. Schiller, Agostino Cortelezzi, Xavier Troussard, Nai Shun Yao, Mirjana Gotic, Shannon Marshall, Tamar Tadmor, Michael Doubek, Ira Pastan, Wyndham H. Wilson, Kemal Balic, Gail J. Roboz, Sascha Dietrich, Peng He, Marco Gobbi, Ronan T. Swords, Francis J. Giles, Loree Larratt, Tadeusz Robak, Dimitri Breems, Tanya Siddiqi, Nathan Standifer, Giuseppe Saglio, Larry Bacon, Douglas E. Gladstone, Krimo Bouabdallah, Pier Luigi Zinzani, Farhad Ravandi, Julio Delgado, Mathias J. Rummel, Cecilia Arana Yi, Frédéric Maloisel, Claire Dearden, Stéphane Leprêtre, National Cancer Institute [Bethesda] (NCI-NIH), National Institutes of Health [Bethesda] (NIH), Royal Marsden NHS Foundation Trust, University of Bologna, Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), Service d’Hématologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Medical University of Łódź (MUL), Johns Hopkins University (JHU), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Universität Heidelberg [Heidelberg], Clinical Center of Serbia (KCS), University of Alberta, Universiteit Gent = Ghent University [Belgium] (UGENT), David Geffen School of Medicine [Los Angeles], University of California [Los Angeles] (UCLA), University of California-University of California, University of Miami [Coral Gables], St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Università degli Studi di Siena = University of Siena (UNISI), CHU Bordeaux [Bordeaux], Ziekenhuis Netwerk Antwerpen (ZNA), Università degli Studi di Milano [Milano] (UNIMI), Northwestern University Feinberg School of Medicine, Faculty of Science [Brno] (SCI / MUNI), Masaryk University [Brno] (MUNI), Haukeland University Hospital, University of Bergen (UiB), Ospedale Policlinico San Martino [Genoa], Medical University of Gdańsk, Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Clinique Sainte Anne [Strasbourg], MD Anderson Cancer Center [Houston], The University of Texas Health Science Center at Houston (UTHealth), Infection et inflammation (2I), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Justus-Liebig-Universität Gießen (JLU), City of Hope National Medical Center, Bnai Zion Medical Center [Israël], Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), The University of New Mexico [Albuquerque], University of Turin, New York Presbyterian Hospital, MedImmune, University of Bologna/Università di Bologna, Universiteit Gent = Ghent University (UGENT), University of California (UC)-University of California (UC), Università degli Studi di Milano = University of Milan (UNIMI), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Justus-Liebig-Universität Gießen = Justus Liebig University (JLU), Università degli studi di Torino = University of Turin (UNITO), Normandie, Université, Kreitman, Robert J, Dearden, Claire, Zinzani, Pier Luigi, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas E, le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri A, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjorn Tore, Gobbi, Marco, Hellmann, Andrzej, Lepretre, Stephane, Maloisel, Frederic, Ravandi, Farhad, Rousselot, Philippe, Rummel, Mathia, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia Arana, Saglio, Giuseppe, Roboz, Gail J, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, and Giles, Francis

Subjects
0301 basic medicine, Male, [SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology, Cancer Research, ERADICATION, Peripheral edema, Salvage therapy, Gastroenterology, Moxetumomab pasudotox, 0302 clinical medicine, Medicine and Health Sciences, Medicine, Aged, 80 and over, Leukemia, Hairy Cell, Remission Induction, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, Middle Aged, Prognosis, 3. Good health, Survival Rate, Tolerability, Oncology, 030220 oncology & carcinogenesis, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Female, Moxetumomab pasudotox hairy cell leukemia, medicine.symptom, Adult, medicine.medical_specialty, Bacterial Toxins, Exotoxins, MINIMAL RESIDUAL DISEASE, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, DIAGNOSIS, Article, 03 medical and health sciences, Refractory, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, Humans, Hairy cell leukemia, RITUXIMAB, IMMUNOHISTOCHEMISTRY, Survival rate, TERM-FOLLOW-UP, Aged, Salvage Therapy, CLADRIBINE, business.industry, medicine.disease, EFFICACY, Minimal residual disease, 030104 developmental biology, ANTIBODY, Drug Resistance, Neoplasm, PATTERNS, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

International audience; This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/ refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Published
2018
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