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25 results on '"Taszner, M."'

1. Safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma

Author

Kim, T.M., Taszner, M., Novelli, S., Cho, S-G., Villasboas, J.C., Merli, M., Jiménez-Ubieto, A., Tessoulin, B., Poon, L.M., Tucker, D., Walewski, J., Yi, S., Song, Y., Chong, G., Bachy, E., Guidez, S., Alonso, A., Jagadeesh, D., Zhang, W., Magnano, L., Iskierka-Jażdżewska, E., Tani, M., Shen, B., Uppala, A., Zhu, M., Shariff, S., Brouwer-Visser, J., Chaudhry, A., Mohamed, H., Ambati, S., and Luminari, S.

Published
2024
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2. ODRONEXTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (FL) GRADE 1–3A: RESULTS FROM A PRESPECIFIED ANALYSIS OF THE PIVOTAL PHASE II STUDY ELM‐2

Author

Novelli, S., primary, Luminari, S., additional, Taszner, M., additional, Cho, S., additional, Le Gouill, S., additional, Poon, M., additional, Villasboas, J. C., additional, Champion, R., additional, Bachy, E., additional, Guidez, S., additional, Alonso, A., additional, Jagadeesh, D., additional, Merli, M., additional, Tucker, D., additional, Cai, J., additional, Leite de Oliveira, C., additional, Zhu, M., additional, Chaudhry, A., additional, Mohamed, H., additional, Ambati, S., additional, and Kim, T. M., additional

Published
2023
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3. Outpatient treatment with 2 cycles of Bendamustine, Gemcitabine and Dexamethasone is Effective and Safe in r/r Hodgkin Lymphoma—Polish Lymphoma Research Group Study

Author

Paszkiewicz‐Kozik, E., primary, Kurlapski, M., additional, Swoboda, R., additional, Subocz, E., additional, Szymanski, M., additional, Taszner, M., additional, Wicherska‐Pawlowska, K., additional, Koclega, A., additional, Domanska‐Czyz, K., additional, Swierkowska, M., additional, Woszczyk, D., additional, Targonski, L., additional, Chmielowska, E., additional, Dabrowska‐Iwanicka, A., additional, Ostrowska, B., additional, Romejko‐Jarosinska, J., additional, Kotarska, M., additional, Druzd‐Sitek, A., additional, Konecki, R., additional, Mroz‐Zycinska, E., additional, Poplawska, L., additional, Borawska, A., additional, Rybka, J., additional, Michalski, W., additional, Rybski, S., additional, Halka, J., additional, Czyz, A., additional, Giebel, S., additional, Walewski, J., additional, and Zaucha, J., additional

Published
2023
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5. OFATUMUMAB WITH IVAC FOR DLBCL PATIENTS WHO FAILED R-CHOP AND WERE NOT CANDIDATES FOR HIGH-DOSE THERAPY AND ASCT - PHASE 2 TRIAL OF THE POLISH LYMPHOMA RESEARCH GROUP (PLRG-8)

Author

Paszkiewicz-Kozik, E., primary, Michalski, W., additional, Taszner, M., additional, Knopińska-Posłuszny, W., additional, Mordak-Domagała, M., additional, Najda, J., additional, Borawska, A., additional, Romejko-Jarosińska, J., additional, Chełstowska, M., additional, Świerkowska, M., additional, Dąbrowska-Iwanicka, A., additional, Malenda, A., additional, Druzd-Sitek, A., additional, Konecki, R., additional, Kuniega, B., additional, Osowiecki, M., additional, Ostrowska, B., additional, Szpila, T., additional, Domańska-Czyż, K., additional, Szymański, M., additional, Targoński, Ł., additional, Poplawska, L., additional, Kotarska, M., additional, Giebel, S., additional, Lange, A., additional, Pluta, A., additional, Warzocha, K., additional, Zaucha, J., additional, Rymkiewicz, G., additional, and Walewski, J., additional

Published
2019
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6. Cardiopoietic cell therapy for advanced ischemic heart failure : results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

Author

Bartunek, Jozef, Terzic, Andre, Davison, Beth A, Filippatos, Gerasimos S, Radovanovic, Slavica, Beleslin, Branko, Merkely, Bela, Musialek, Piotr, Wojakowski, Wojciech, Andreka, Peter, Horvath, Ivan G, Katz, Amos, Dolatabadi, Dariouch, El Nakadi, Badih, Arandjelovic, Aleksandra, Edes, Istvan, Seferovic, Petar M, Obradovic, Slobodan, Vanderheyden, Marc, Jagic, Nikola, Petrov, Ivo, Atar, Shaul, Halabi, Majdi, Gelev, Valeri L, Shochat, Michael K, Kasprzak, Jaroslaw D, Sanz Ruiz, Ricardo, Heyndrickx, Guy R, Nyolczas, Noémi, Legrand, Victor, Guédès, Antoine, Heyse, Alex, Moccetti, Tiziano, Fernandez Aviles, Francisco, Jimenez Quevedo, Pilar, Bayes Genis, Antoni, Hernandez Garcia, Jose Maria, Ribichini, Flavio, Gruchala, Marcin, Waldman, Scott A, Teerlink, John R, Gersh, Bernard J, Povsic, Thomas J, Henry, Timothy D, Metra, Marco, Hajjar, Roger J, Tendera, Michal, Behfar, Atta, Alexandre, Bertrand, Seron, Aymeric, Stough, Wendy Gattis, Sherman, Warren, Cotter, Gad, Wijns, W. i. l. l. i. a. m. Collaborators Clinical investigators, Dens, sites Belgium: Ziekenhuis Oost Limburg: J., Dupont, M., Mullens, W., Janssens, M., Dolatabadi, Hoˆpital Civil de Charleroi: D., De Bruyne, Y., Lalmand, J., Dubois, P., El Nakadi, B., Aminian, A., De Vuyst, E., Gurnet, P., Gujic, M., Blankoff, I., Guedes, CHU Mont Godinne UCL: A., Gabriel, L., Seldrum, S., Doyen, C., Andre´, M., Heyse, AZ Glorieux: A., Van Durme, F., Verschuere, J., Legrand, Domaine Universitaire du Sart Tilman: V., Gach, O., D’Orio, V., Davin, L., Lancellotti, P., Baudoux, E., Ancion, A., Dulgheru, R., Vanderheyden, OLV Ziekenhuis Aalst – Cardiologie: M., Bartunek, J., Wijns, W., Verstreken, S., Penicka, . M., Gelev, P. Meeus Bulgaria: Tokuda Hospital Sofia: V., Zheleva Kichukova, I., Parapunova, R., Melamed, R., Sardovski, S., Radev, O., Yordanov, A., Radinov, A., Nenov, D., Amine, I., Petrov, City Hospital Clinic Cardiology Center: I., Kichukov, K., Nikitasov, L., Stankov, Z., Stoyanov, H., Tasheva Dimitrova, I., Angelova, M., Dimitrov, E., Minchev, M., Garvanski, I., Botev, C., Polomski, P., Alexandrovska University Hospital, Vassilev, Sofia: D., Karamfiloff, K., Tarnovska Kadreva, R., Vladimirova, L., Dimitrov, G., Hadzhiev, E., Tzvetkova, G., Andreka, . M. Atanasova Hungary: Gottsegen Gyo¨ rgy Orszagos Kardiologiai Inte´zet: P., Fontos, G., Fabian, J., Csepregi, A., Uzonyi, G., Gelei, A., Edes, Debreceni Egyetem Orvos e´s Ege´szse´gtudomanyi Centrum Altalanos Orvostudomanyi Kar Kardiologia Inte´zet: I., Balogh, L., Vajda, G., Darago, A., Gergely, S., Fulop, T., Jenei, C., Horvath, Pe´csi Tudomanyegyetem Klinikai Ko¨zpont Szıvgyogyaszati Klinika: I., Magyari, B., Nagy, A., Cziraki, A., Faludi, R., Kittka, B., Alizadeh, H., Merkely, Semmelweis Egyetem Varosmajori Szıv e´s Ergyogyaszati Klinika: B., Geller, L., Farkas, P., Szombath, G., Foldes, G., Skopal, J., Kovacs, A., Kosztin, A., Gara, E., Sydo, N., Nyolczas, MH Ege´szse´gu¨gyi Ko¨zpont Kardiologiai Osztaly: N., Kerecsen, G., Korda, A., Kiss, . M., Borsanyi, T., Polgar, B., Muk, B., Sharif, Z. Bari Ireland: HRB Clinical Research Facility: F., Atar, Y. M. Smyth Israel:Western Galilee Hospital: S., Shturman, A., Akria, L., Kilimnik, M., Brezins, M., Halabi, Ziv Medical Center: M., Dally, N., Goldberg, A., Aehab, K., Rosenfeld, I., Levinas, T., Saleem, D., Katz, Barzilai Medical Center: A., Plaev, T., Drogenikov, T., Nemetz, A., Barshay, Y., Jafari, J., Orlov, I., Nazareth Hospital EMMS: M. Omory, N. Kogan Nielsen, Shochat, Hillel Yaffe Medical Center: M., Shotan, A., Frimerman, A., Meisel, S., Asif, A., Sofer, O., Blondheim, D. S., Vazan, A., Metra, L. Arobov Italy: A. O. Spedali Civili di Brescia: M., Bonadei, I., Inama, L., Chiari, E., Lombardi, C., Magatelli, M., Russo, D., Lazzarini, V., Carubelli, V., Vassanelli, AOUI Verona – Borgo Trento Hospital: C., Ribichini, Flavio Luciano, Bergamini, C., Krampera, Mauro, Cicoria, M. A., Zanolla, L., Dalla Mura, D., Gambaro, A., Rossi, A., Pesarini Poland: Jagiellonian University Department of Cardiac, G., Musialek, Vascular Diseases at John Paul II Hospital in Krakow: P., Mazurek, A., Drabik, L., Ka˛dzielski, A., Walter, Z., Dzieciuch Rojek, M., Rubis, P., Plazak, . W., Tekieli, L., Podolec, J., Orczyk, W., Sutor, U., Zmudka, K., Olszowska, M., Podolec, P., Gruchala, Uniwersyteckie Centrum Kliniczne: M., Ciecwierz, D., Mielczarek, M., Burakowski, S., Chmielecki, M., Zielinska, M., Frankiewicz, A., Wdowczyk, J., Stopczynska, I., Bellwon, J., Mosakowska, K., Nadolna, R., Wroblewska, J., Rozmyslowska, M., Rynkiewicz, M., Marciniak, I., Raczak, G., Tarnawska, M., Taszner, M., Kasprzak, Bieganski Hospital: J., Plewka, M., Fiutowska, D., Rechcinski, T., Lipiec, P., Sobczak, M., Weijner Mik, P., Wraga, M., Krecki, R., Markiewicz, M., Haval Qawoq, D., Wojakowski, Gornosla˛skie Centrum Medyczne Sla˛skie j. Akademii Medycznej: W., Ciosek, J., Dworowy, S., Gaszewska Zurek, E., Ochala, A., Cybulski, W., Jadczyk, T., Wanha, W., Parma, Z., Kozlowski, M., Dzierzak, M., Markiewicz Serbia: Clinical Hospital Center Zvezdara, M., Arandjelovic, Cardiology Clinic: A., Sekularac, N., Boljevic, D., Bogdanovic, A., Zivkovic, S., Cvetinovic, N., Loncar, G., Clinical Centre of Serbia, Beleslin, Cardiology Clinic: B., Nedeljkovic, M., Trifunovic, D., Giga, V., Banovic, M., Nedeljkovic, I., Stepanovic, J., Vukcevic, V., Djordjevic Dikic, A., Dobric, M., Obrenovic Kircanski, B., Seferovic, Cardiology Clinic: P., Orlic, D., Tesic, M., Petrovic, O., Milinkovic, I., Simeunovic, D., Jagic, Clinical Center of Kragujevac: N., Tasic, M., Nikolic, D., Miloradovic, V., Djurdjevic, P., Sreckovic, M., Zornic, N., Clinical Hospital Center Bezanijska Kosa, Radovanovic, Cardiology Department: S., Saric, J., Hinic, S., Djokovic, A., Ðordevic, S., Bisenic, V., Markovic, O., Stamenkovic, S., Malenkovic, V., Tresnjak, J., Misic, G., Cotra, D., Tomovic, L., Vuckovic, V., Clinic of Emergency Internal Medicine, Obradovic, Military Medical Academy: S., Jovic, Z., Vukotic, S., Markovic, D., Djenic, N., Ristic Andjelkov, A., Bayes Genis, D. Ljubinka Spain: Hospital Universitario Germans Trias I. Pujol: A., Rodriguez Leor, O., Labata, C., Vallejo, N., Ferrer, E., Batlle, M., Fernandez Aviles, Hospital General Universitario Gregorio Mara~non: F., Sanz Ruiz, R., Casado, A., Loughlin, G., Zatarain, E., Anguita, J., Ferna ndez Santos, M. E., Pascual, C., Bermejo, J., Hernandez Garcia, Hospital Clinico Universitario Virgen de la Victoria: J. M., Jimenez Navarro, M., Dominguez, A., Carrasco, F., Mu~noz, A., Garcia Pinilla, J. M., Ruiz, J., Queipo de Llano, M. P., Hernandez, A., Fernandez, A., Jimenez Quevedo, Hospital Clinico San Carlos: P., Guerra, R., Biagioni, C., Gonzalez, R. A., Gomez deDiego, J. J., Mansson Broberg, L. Perez de Isla Sweden: Karolinska University Hospital: A., Sylve´n, C., Leblanc, K., Winter, R., Blomberg, P., Gunyeli, E., Ruck, A., Silva, C., Fo¨rstedt Switzerland: CardioCentro Ticino, J., Moccetti, Switzerland: T., Rossi, M., Pasotti, E., Petrova, I., Crljenica, C., Monti, C., Murzilli, R., Su¨rder, D., Moccetti, M., Turchetto, L., Locicero, V., Chiumiento, L., Maspoli, S., Mombelli, M., Anesini, A., Biggiogero, M., Ponti, G., Camporini, C., Polledri, S., Hill, G. Dolci United Kingdom: Kings College Hospital: J., Plymen, C., Amin Youssef, G., Mcdonagh, T., Drasar, E., Mijovic, A., Jouhra, F., Mcloman, D., Dworakowski, R., Webb, I., Byrne, J., and Potter, V.

Subjects
0301 basic medicine, Male, Cardiopoiesis, Cardiovascular disease, Disease severity, Marker, Precision medicine, Regenerative medicine, Stem cell, Target population, Adult, Aged, Double-Blind Method, Female, Heart Failure, Humans, Mesenchymal Stem Cell Transplantation, Middle Aged, Myocardial Ischemia, Prospective Studies, Treatment Outcome, Young Adult, Cardiology and Cardiovascular Medicine, Cell- and Tissue-Based Therapy, mesenchymal stem-cells, 030204 cardiovascular system & hematology, Cardiorespiratory Medicine and Haematology, outcomes, Fast-Track Clinical Research, Sudden cardiac death, 0302 clinical medicine, Ischemia, cardiovascular disease, Clinical endpoint, target population, CHART Program, Ejection fraction, bone-marrow, Heart Failure/Cardiomyopathy, 3. Good health, Cohort, Cardiology, Fast Track, disease severity, delivery, medicine.medical_specialty, precision medicine, Clinical Sciences, regenerative medicine, 03 medical and health sciences, cardiopoiesis, Internal medicine, medicine, Adverse effect, marker, disease, business.industry, medicine.disease, mortality, Confidence interval, Clinical trial, stem cell, Editor's Choice, 030104 developmental biology, predictors, Cardiovascular System & Hematology, Heart failure, business
Abstract

Altres ajuts: This work was supported by Celyad, SA (Mont-Saint-Guibert, Belgium). Celyad has received research grants from the Walloon Region (Belgium, DG06 funding). Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.

Published
2017

8. TRIAL IN PROGRESS: ODRONEXTAMAB, A CD20×CD3 BISPECIFIC ANTIBODY, FOR THE TREATMENT OF RELAPSED/REFRACTORY MARGINAL ZONE LYMPHOMA (R/R MZL)—A COHORT FROM THE ELM‐2 STUDY.

Author

Cho, S., Kim, T. M., Taszner, M., Chen, T. Y., Chaudhry, A., Ufkin, M., Uppala, A., Sabir, A., Mohamed, H., Ambati, S., and Bachy, E.

Subjects
MUCOSA-associated lymphoid tissue lymphoma, BISPECIFIC antibodies
Abstract

The MZL cohort is planned to include 78 patients, who will receive IV odronextamab monotherapy until disease progression or other protocol-defined reason for treatment discontinuation. In the Phase 1 ELM-1 study, odronextamab monotherapy showed antitumor activity and a manageable safety profile in a range of I R i / I R i B-NHL subtypes, including MZL ( I n i = 6; ORR 67%) (Bannerji et al. B Introduction: b MZL is a heterogeneous disease comprising 3 subtypes, extra-nodal MZL of mucosa-associated lymphoid tissue, nodal MZL, and splenic MZL. [Extracted from the article]

Published
2023
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9. AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTATION FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA (PCNSL). REAL‐WORLD REPORT OF POLISH LYMPHOMA RESEARCH GROUP.

Author

Ostrowska, B., Domanska‐Czyz, K., Giza, A., Taszner, M., Romejko‐Jarosinska, J., Targonski, L., Poplawska, L., Konecki, R., Kotarska, M., Szymanski, M., Borawska, A., Swierkowska, M., Dabrowska‐Iwanicka, A., Druzd‐Sitek, A., Paszkiewicz‐Kozik, E., Mroz‐Zycinska, E., Osowiecki, M., Zimowska‐Curylo, D., Owczarek‐Kaczmarek, J., and Tajer, J.

Subjects
STEM cell transplantation, HEMATOPOIETIC stem cell transplantation, CENTRAL nervous system, RESEARCH teams, LYMPHOMAS
Abstract

B Conclusion: b HDC-ASCT based on conditioning regimen consisted of carmustine, etoposide and thiotepa (BET) is a relatively safe and highly effective treatment for PCNSL patients. B Introduction: b High-dose chemotherapy with autologous stem-cell transplantation (HDC-ASCT) is now the preferred consolidation strategy for young PCNSL patients. At the end of induction 29 (64.5%) patients obtained CR/CRun (19/10 respectively), with additional 5 (11%) patients with no evidence of disease at baseline, and 11 (24.5%) in PR, based on standard CT/MRI assessment. [Extracted from the article]

Published
2023
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11. Poster session II * Thursday 9 December 2010, 14:00-18:00

Author

Pabari, P. A., primary, Kyriacou, A., additional, Moraldo, M., additional, Unsworth, B., additional, Baruah, R., additional, Sutaria, N., additional, Hughes, A., additional, Mayet, J., additional, Francis, D. P., additional, Uejima, T., additional, Loboz, K., additional, Antonini-Canterin, F., additional, Polombo, C., additional, Carerj, S., additional, Vinereanu, D., additional, Evangelista, A., additional, Leftheriotis, G., additional, Fraser, A. G., additional, Kiotsekoglou, A., additional, Govindan, M., additional, Govind, S. C., additional, Saha, S. K., additional, Camm, A. J., additional, Azcarate, P. M., additional, Castano, S., additional, Rodriguez-Manero, M., additional, Arraiza, M., additional, Levy, B., additional, Barba, J., additional, Rabago, G., additional, Bastarrika, G., additional, Nemes, A., additional, Takacs, R., additional, Varkonyi, T., additional, Gavaller, H., additional, Baczko, I., additional, Forster, T., additional, Wittmann, T., additional, Papp, J. G., additional, Lengyel, C., additional, Varro, A., additional, Tumasyan, L. R., additional, Adamyan, K. G., additional, Savu, O., additional, Mieghem, T., additional, Dekoninck, P., additional, Gucciardo, L., additional, Jurcut, R., additional, Giusca, S., additional, Popescu, B. A., additional, Ginghina, C., additional, Deprest, J., additional, Voigt, J. U., additional, Versiero, M., additional, Galderisi, M., additional, Esposito, R., additional, Rapacciuolo, A., additional, Esposito, G., additional, Raia, R., additional, Morgillo, T., additional, Piscione, F., additional, De Simone, G., additional, Oraby, M. A., additional, Maklady, F. A., additional, Mohamed, E. M., additional, Eraki, A. Z., additional, Zaliaduonyte-Peksiene, D., additional, Tamuleviciute, E., additional, Janenaite, J., additional, Marcinkeviciene, J., additional, Mizariene, V., additional, Bucyte, S., additional, Vaskelyte, J., additional, Trifunovic, D., additional, Nedeljkovic, I., additional, Popovic, D., additional, Ostojic, M., additional, Vujisic-Tesic, B., additional, Petrovic, M., additional, Stankovic, S., additional, Sobic-Saranovic, D., additional, Banovic, M., additional, Dikic-Djordjevic, A., additional, Savino, K., additional, Lilli, A., additional, Grikstaite, E., additional, Giglio, V., additional, Bordoni, E., additional, Maragoni, G., additional, Cavallini, C., additional, Ambrosio, G., additional, Jakovljevic, B., additional, Beleslin, B., additional, Nedeljkovic, M., additional, Petrovic, O., additional, Moral, S., additional, Rodriguez-Palomares, J., additional, Descalzo, M., additional, Marti, G., additional, Pineda, V., additional, Mahia, P., additional, Gutierrez, L., additional, Gonzalez-Alujas, T., additional, Garcia-Dorado, D., additional, Schnell, F., additional, Donal, E., additional, Thebault, C., additional, Bernard, A., additional, Corbineau, H., additional, Le Breton, H., additional, Kochanowski, J., additional, Scislo, P., additional, Piatkowski, R., additional, Roik, M., additional, Marchel, M., additional, Kosior, D., additional, Opolski, G., additional, Lesniak-Sobelga, A. M., additional, Wicher-Muniak, E., additional, Kostkiewicz, M., additional, Olszowska, M., additional, Suchon, E., additional, Klimeczek, P., additional, Banys, P., additional, Pasowicz, M., additional, Tracz, W., additional, Podolec, P., additional, Laynez, A., additional, Hoefsten, D. E., additional, Loegstrup, B. B., additional, Norager, B., additional, Moller, J. E., additional, Flyvbjerg, A., additional, Egstrup, K., additional, Streb, W., additional, Szulik, M., additional, Nowak, J., additional, Markowicz-Pawlus, E., additional, Duszanska, A., additional, Sedkowska, A., additional, Kalarus, Z., additional, Kukulski, T., additional, Spinelli, L., additional, Morisco, C., additional, Assante Di Panzillo, E., additional, Buono, F., additional, Crispo, S., additional, Trimarco, B., additional, Hawary, A. A., additional, Nasr, G. M., additional, Fawzy, M. M., additional, Faber, L., additional, Scholtz, W., additional, Boergermann, J., additional, Wiemer, M., additional, Kleikamp, G., additional, Bogunovic, N., additional, Dimitriadis, Z., additional, Gummert, J., additional, Hering, D., additional, Horstkotte, D., additional, Luca', F., additional, Gelsomino, S., additional, Lorusso, R., additional, Caciolli, S., additional, Carella, R., additional, Bille', G., additional, De Cicco, G., additional, Pazzagli, V., additional, Gensini, G. F., additional, Borowiec, A., additional, Dabrowski, R., additional, Janas, J., additional, Kraska, A., additional, Firek, B., additional, Kowalik, I., additional, Szwed, H., additional, Marcus, K. A., additional, De Korte, C. L., additional, Feuth, T., additional, Thijssen, J. M., additional, Kapusta, L., additional, Dahl, J., additional, Videbaek, L., additional, Poulsen, M. K., additional, Pellikka, P. A., additional, Veien, K., additional, Andersen, L. I., additional, Haghfelt, T., additional, Haberka, M., additional, Mizia - Stec, K., additional, Adamczyk, T., additional, Mizia, M., additional, Chmiel, A., additional, Pysz, P., additional, Sosnowski, M., additional, Gasior, Z., additional, Trusz - Gluza, M., additional, Tendera, M., additional, Niklewski, T., additional, Wilczek, K., additional, Chodor, P., additional, Podolecki, T., additional, Frycz-Kurek, A., additional, Zembala, M., additional, Yurdakul, S., additional, Yildirimturk, O., additional, Tayyareci, Y., additional, Memic, K., additional, Demiroglu, I. C. C., additional, Aytekin, S., additional, Garcia Alonso, C. J., additional, Ferrer Sistach, E., additional, Delgado, L., additional, Lopez Ayerbe, J., additional, Vallejo Camazon, N., additional, Gual Capllonch, F., additional, Espriu Simon, M., additional, Ruyra, X., additional, Caballero Parrilla, A., additional, Bayes Genis, A., additional, Lecuyer, L., additional, Berrebi, A., additional, Florens, E., additional, Noghin, M., additional, Huerre, C., additional, Achouh, P., additional, Zegdi, R., additional, Fabiani, J. N., additional, De Chiara, B., additional, Moreo, A., additional, Musca, F., additional, De Marco, F., additional, Lobiati, E., additional, Belli, O., additional, Mauri, F., additional, Klugmann, S., additional, Caballero, A., additional, Vallejo, N., additional, Gonzalez Guardia, A., additional, Nunez Aragon, R., additional, Bosch, C., additional, Ferrer, E., additional, Pedro Botet, M. 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G., additional, Carvalho, V., additional, Jorge, C., additional, Silva, D., additional, Gato Varela, M., additional, Martins, S., additional, Brito, D., additional, Lopes, M. G., additional, Tripodi, E., additional, Miserrafiti, B., additional, Montemurro, V., additional, Scali, R., additional, Tripodi, P., additional, Winkler, A., additional, Madej, A., additional, Hausmanowa-Petrusewicz, I., additional, Fijalkowski, M., additional, Koprowski, A., additional, Jaguszewski, M., additional, Galaska, R., additional, Taszner, M., additional, Rynkiewicz, A., additional, Citro, R., additional, Rigo, F., additional, Provenza, G., additional, Ciampi, Q., additional, Patella, M. M., additional, D'andrea, A., additional, Vriz, O., additional, Astarita, C., additional, Bossone, E., additional, Heggemann, F., additional, Walter, T. H., additional, Kaelsch, T. H., additional, Sueselbeck, T., additional, Papavassiliu, T. H., additional, Borggrefe, M., additional, Haghi, D., additional, Monk-Hansen, T., additional, Have Dall, C., additional, Bisgaard Christensen, S., additional, Snoer, M., additional, Gustafsson, F., additional, Rasmusen, H., additional, Prescott, E., additional, Finocchiaro, G., additional, Pinamonti, B., additional, Merlo, M., additional, Barbati, G., additional, Di Lenarda, A., additional, Bussani, R., additional, Sinagra, G., additional, Butz, T., additional, Lang, C. N., additional, Meissner, A., additional, Plehn, G., additional, Yeni, H., additional, Langer, C., additional, Trappe, H. J., additional, Gu, X., additional, Gu, X. Y., additional, He, Y. H., additional, Li, Z. A., additional, Han, J. C., additional, Chen, J., additional, Gaudron, P., additional, Niemann, M., additional, Herrmann, S., additional, Hu, K., additional, Bijnens, B., additional, Hillenbrand, H., additional, Beer, M., additional, Ertl, G., additional, Weidemann, F., additional, Mazzone, A., additional, Mariani, M., additional, Foffa, I., additional, Vianello, A., additional, Del Ry, S., additional, Bevilacqua, S., additional, Andreassi, M. G., additional, Glauber, M., additional, Berti, S., additional, Grabowski, M., additional, Postula, M., additional, Dragulescu, A., additional, Van Arsdell, G., additional, Al-Radi, O., additional, Caldarone, C., additional, Mertens, L., additional, Lee, K. J., additional, Casula, R. P., additional, Yadav, H., additional, Cherian, A., additional, Hughes, A. D., additional, Vitarelli, A., additional, D'orazio, S., additional, Nguyen, B. L., additional, Iorio, G., additional, Battaglia, D., additional, Caranci, F., additional, Padella, V., additional, Capotosto, L., additional, Alessandroni, L., additional, Barilla, F., additional, Cardin, C., additional, Hascoet, S., additional, Saudron, M., additional, Caudron, G., additional, Arnaudis, B., additional, Acar, P., additional, Sun, M. M., additional, Shu, X. H., additional, Pan, C. Z., additional, Fang, X. Y., additional, Kong, D. H., additional, Fang, F., additional, Zhang, Q., additional, Chan, Y. S., additional, Xie, J. M., additional, Yip, W. K., additional, Lam, Y. Y., additional, Sanderson, J. E., additional, Yu, C. M., additional, Rosca, M., additional, O' Connor, K., additional, Romano, G., additional, Magne, J., additional, Calin, A., additional, Muraru, D., additional, Pierard, L., additional, Lancellotti, P., additional, Roushdy, A., additional, Elfiky, I., additional, El Shahid, G., additional, Elfiky, A., additional, El Sayed, M., additional, Wierzbowska-Drabik, K., additional, Chrzanowski, L., additional, Kapusta, A., additional, Plonska-Goscinak, E., additional, Krzeminska-Pakula, M., additional, Kurpesa, M., additional, Rechcinski, T., additional, Trzos, E., additional, Kasprzak, J. D., additional, Ersboll, M. K., additional, Valeur, N., additional, Mogensen, U. M., additional, Andersen, M., additional, Hassager, C., additional, Sogaard, P., additional, Kober, L. V., additional, Kloeckner, M., additional, Hayat, D., additional, Dussault, C., additional, Lellouche, N., additional, Elbaz, N., additional, Demopoulos, A., additional, Hatzigeorgiou, G., additional, Leontiades, E., additional, Motsi, A., additional, Karatasakis, G., additional, Athanassopoulos, G., additional, Zycinski, P., additional, Kasprzak, J., additional, Vazquez Alvarez, M. C., additional, Medrano Lopez, C., additional, Camino Lopez, M., additional, Granja, S., additional, Zunzunegui Martinez, J. L., additional, Maroto Alvaro, E., additional, Tsai, W.-C., additional, Chen, J.-Y., additional, Liu, Y.-W., additional, Lin, C.-C., additional, Tsai, L.-M., additional, Gomes, D. C., additional, Robalo Martins, S., additional, Gois, M. R., additional, Ribeiro, S., additional, Nunes Diogo, A., additional, Sengupta, P., additional, Di Bella, G., additional, Caracciolo, G., additional, Lentini, S., additional, Kinova, E., additional, Zlatareva, N., additional, Goudev, A., additional, Papagiannis, N., additional, Mpouki, M., additional, Papagianni, A., additional, Vorria, M., additional, Mpenetos, G., additional, Lytra, D., additional, Papadopoulou, E., additional, Sgourakis, P., additional, Malakos, J., additional, Kyriazis, J., additional, Kodali, V., additional, Toole, R., additional, Gopal, A. S., additional, Celutkiene, J., additional, Rudys, A., additional, Grabauskiene, V., additional, Glaveckaite, S., additional, Sadauskiene, E., additional, Lileikiene, Z., additional, Bickauskaite, N., additional, Ciburiene, E., additional, Skorniakov, V., additional, Laucevicius, A., additional, Attenhofer Jost, C. H., additional, Pfyffer, M., additional, Lindquist, R., additional, Santos, J. L. F., additional, Coelho, O. R. C., additional, Mady, C. M., additional, Picard, M. H. P., additional, Salemi, V. M. C., additional, Funk, L., additional, Prull, M. W., additional, Shih, J.-Y., additional, Huang, Y.-Y., additional, O'connor, K., additional, Moonen, M., additional, Pierard, L. A., additional, Cozma, D. C., additional, Mornos, C., additional, Ionac, A., additional, Petrescu, L., additional, Dragulescu, D., additional, Dan, R., additional, Popescu, I., additional, Dragulescu, S. I., additional, Von Lueder, T. G., additional, Hodt, A., additional, Gjerdalen, G. F., additional, Andersen, T. E., additional, Solberg, E. E., additional, Steine, K., additional, Van Mieghem, T., additional, Rostek, M., additional, Pikto-Pietkiewicz, W., additional, Dluzniewski, M., additional, Antoniewicz, A., additional, Poletajew, S., additional, Borowka, A., additional, Pasierski, T., additional, Malyutina, S. K., additional, Ryabikov, M., additional, Ragino, J., additional, Ryabikov, A., additional, Sitia, S., additional, Tomasoni, L., additional, Atzeni, F., additional, Gianturco, L., additional, Sarzi-Puttini, P., additional, De Gennaro Colonna, V., additional, Turiel, M., additional, Gutierrez, F. R., additional, Lefhtheriotis, G., additional, Hurst, R. T., additional, Nelson, M. R., additional, Mookadam, F., additional, Thota, V., additional, Emani, U., additional, Al Harthi, M., additional, Stepanek, J., additional, Cha, S., additional, Lester, S. J., additional, Ho, E. M. M., additional, Hemeryck, L., additional, Hall, M., additional, Scott, K., additional, Bennett, K., additional, Mahmud, A., additional, Daly, C., additional, King, G., additional, Murphy, R. T., additional, Brown, A. S., additional, Teske, A. J., additional, D'Hooge, J., additional, Claus, P., additional, Rademakers, F., additional, Santos, L., additional, Cortez-Dias, N., additional, Goncalves, S., additional, Almeida Ribeiro, M., additional, Bordalo E Sa, A., additional, Magnino, C., additional, Marcos-Alberca, P., additional, Milan, A., additional, Almeria, C., additional, Caniadas, V., additional, Rodrigo, J. L., additional, Perez De Isla, L., additional, Zamorano, J. L., additional, Gustafsson, U., additional, Larsson, M., additional, Lindqvist, P., additional, Brodin, L., additional, Waldenstrom, A., additional, Roosens, B., additional, Hernot, S., additional, Droogmans, S., additional, Van Camp, G., additional, Lahoutte, T., additional, Cosyns, B., additional, Rao, C. M., additional, Aguglia, D., additional, Casciola, G., additional, Imbesi, C., additional, Marvelli, A., additional, Sgro, M., additional, Benedetto, D., additional, Tripepi, R., additional, Zoccali, C., additional, Benedetto, F. A., additional, Badano, L. P., additional, Cardillo, M., additional, Del Mestre, L., additional, Gianfagna, P., additional, Proclemer, A., additional, Tschernich, H. D., additional, Mora, B., additional, Base, E., additional, Weber, U., additional, Dumfarth, J., additional, Mukherjee, C., additional, Skaltsiotis, H. S., additional, Kaladaridis, A. K., additional, Bramos, D. B., additional, Kottis, G. K., additional, Antoniou, A. A., additional, Agrios, I. A., additional, Takos, D. T., additional, Vasiladiotis, N. V., additional, Pamboucas, K. P., additional, Toumanidis, S. T. T., additional, Shim, A., additional, Lipec, P., additional, Michalski, B., additional, Wozniakowski, B., additional, Stefanczyk, L., additional, Rotkiewicz, A., additional, Cameli, M., additional, Lisi, M., additional, Padeletti, M., additional, Bigio, E., additional, Bernazzali, S., additional, Tsoulpas, C., additional, Maccherini, M., additional, Henein, M., additional, Mondillo, S., additional, Garcia Lunar, I., additional, Mingo Santos, S., additional, Monivas Palomero, V., additional, Mitroi, C., additional, Beltran Correas, P., additional, Ruiz Bautista, L., additional, Muniz Lozano, A., additional, Gonzalez Gonzalez, M., additional, Pabari, P. A., additional, Stegemann, B., additional, Willson, K., additional, Zeppellini, R., additional, Iavernaro, A., additional, Zadro, M., additional, Carasi, M., additional, De Domenico, R., additional, Rigo, T., additional, Artuso, E., additional, Erente, G., additional, Ramondo, A., additional, Le, T. T., additional, Huang, F. Q., additional, Gu, Y., additional, and Tan, R. S., additional

Published
2010
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13. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): a phase 2 study.

Author

Zinzani PL, Trněný M, Ribrag V, Zilioli VR, Walewski J, Christensen JH, Delwail V, Rodriguez G, Venugopal P, Coleman M, Dartigeas C, Patti C, Pane F, Jurczak W, Taszner M, Paneesha S, Zheng F, DeMarini DJ, Jiang W, Gilmartin A, and Mehta A

Abstract

Background: Parsaclisib is a potent and highly selective PI3Kδ inhibitor that has shown clinical benefit in patients with relapsed/refractory (R/R) B-cell malignancies. In this phase 2 study (CITADEL-205; NCT03235544, EudraCT 2017-003148-19), the efficacy and safety of parsaclisib was evaluated in patients with R/R mantle cell lymphoma (MCL)., Methods: Patients ≥18 years old with pathologically confirmed R/R MCL and prior treatment with 1-3 systemic therapies, with (cohort 1) or without (cohort 2) previous Bruton kinase inhibitor (BTKi) treatment, received oral parsaclisib 20 mg once-daily (QD) for 8 weeks, then either parsaclisib 20 mg once-weekly (weekly dosing group [WG]) or parsaclisib 2.5 mg QD (daily dosing group [DG]). The primary endpoint was objective response rate (ORR)., Findings: At the primary analysis data cutoff on January 15, 2021, 53 patients in cohort 1 (BTKi-experienced) (WG, n = 12; DG: n = 41) and 108 patients in cohort 2 (BTKi-naive) (WG, n = 31; DG: n = 77) had received parsaclisib monotherapy. The BTKi-experienced cohort was closed after an interim analysis demonstrated limited clinical benefit. In the BTKi-naive cohort, the ORR (95% CI) for DG (dosing selected for further study) was 70.1% (58.6%-80.0%), with a complete response rate (95% CI) of 15.6% (8.3%-25.6%) and a median duration of response (95% CI) of 12.1 (9.0-not evaluable) months. Treatment-emergent adverse events (TEAEs) occurred among 90.7% (98/108) of all treated patients in the BTKi-naive cohort. Grade ≥3 TEAEs occurred among 62.0% (67/108) of patients, including diarrhoea (13.9%, 15/108) and neutropenia (8.3%, 9/108). Parsaclisib interruption, reduction, or discontinuation due to TEAEs occurred among 47.2% (51/108), 8.3% (9/108), and 25.0% (27/108) of patients, respectively. Fatal TEAEs were experienced by six patients and determined to be treatment-related in one patient., Interpretation: Parsaclisib, a potent, highly selective, PI3Kδ inhibitor demonstrated meaningful clinical benefits and a manageable safety profile (25.0% discontinuation rate, low incidences of individually reported grade ≥3 or serious adverse events) in R/R MCL patients with no prior BTKi therapy. Limited clinical benefit was observed with parsaclisib monotherapy in patients who had previously received BTKi treatment. Future development of PI3K inhibitors for NHL will require further investigation of dose optimisation to improve safety and long-term survival., Funding: Incyte Corporation., Competing Interests: PLZ reports consulting or advisory role, and involvement of speakers bureau for Beigene, Bristol Myers Squibb, Celltrion, EUSA Pharma, Gilead, Incyte Corporation, Janssen-Cilag, Kyowa Kirin, Merck Sharp & Dohme, Novartis, Roche, Servier, Takeda, and TG Therapeutics; advisory role for ADC Therapeutics, Sandoz, and Secura Bio. MTrněný reports honoraria, consulting or advisory role, travel and accommodations expenses for AbbVie, Bristol Myers Squibb, Gilead Sciences, Janssen, Roche, and Takeda; honoraria, consulting or advisory role for Amgen, Incyte Corporation, and MorphoSys. VR reports research funding for ArgenX and Astex; membership on a board or advisory committee for Bristol Myers Squibb, Epizyme, Gilead, GlaxoSmithKline, Incyte Corporation, Infinity, Merck Sharp & Dohme, Nanostring, and Roche; membership on a board or advisory committee, honoraria for PharmaMar; membership on a board or advisory committee, consultancy for Servier. VRZ reports consulting or advisory role, speakers bureau for Gentili, Gilead, Italfarmaco, Janssen, Merck Sharp & Dohme, Roche, Servier, and Takeda. JW reports research funding for GlaxoSmithKline, Novartis, and Roche; advisory role and lecture honoraria for AbbVie, Amgen, Celgene, Gilead, Janssen, Novartis, Roche, Servier, and Takeda. GR reports consulting or advisory role, and involvement of speakers bureau for Bristol Myers Squibb, Celgene, Janssen, Roche, and Takeda; consulting or advisory role for EUSA Pharma. MC reports research funding for Amgen, Astra Zeneca, BeiGene, Bristol Meyers, Celgene, Gilead, Incyte, Innocare, Johnson and Johnson, Merck, Pharmacyclics; consulting for BeiGene, Epizyme, Gilead. CD reports advisory board for AbbVie, AstraZeneca, Beigene, and Janssen; travel and accommodation expenses for AbbVie, AstraZeneca, and Janssen. CP reports advisory board for Abbvie, Incyte Corporation, and Janssen. FP reports consulting or advisory role, speakers bureau, travel and accommodations expenses for AbbVie (Investigator in sponsored clinical trials), Amgen, Jazz Pharmaceuticals, and Novartis Pharma SAS; consulting or advisory role, travel and accommodations expenses for Daiichi Sankyo; travel and accommodations expenses for Janssen; research funding for Novartis Pharma SAS (Institutional). WJurczak reports research funding for Bayer, Gilead, Incyte Corporation, Mei Pharma, and TG Therapeutics. MTaszner reports consulting or advisory role, travel and accommodations expenses for Roche and Takeda. SP reports honoraria for AbbVie, Bristol Myers Squibb, Celgene, Gilead, and Janssen. FZ reports employment and stock ownership for Incyte Corporation. DJD reports former employment and stock ownership for Incyte Corporation. WJiang reports former employment and stock ownership for Incyte Corporation. AG reports employment and stock ownership for Incyte Corporation. AM reports consultancy, membership on an entity's board of directors or advisory committees, research funding, speakers bureau for Seattle Genetics and TG Therapeutics; research funding for Affimed, Celgene/Bristol Myers Squibb, fortyseven Inc/Gilead, Innate Pharmaceuticals, Juno Pharmaceuticals/Bristol Myers Squibb, Kite/Gilead, Merck, OncoTartis, Roche-Genentech, and Takeda; consultancy, membership on an entity's board of directors or advisory committees, research funding, speakers bureau for Incyte Corporation. JHC, VD, and PV report no relevant disclosures to declare., (© 2023 The Authors.)

Published
2023
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15. Ofatumumab with iphosphamide, etoposide and cytarabine for patients with transplantation-ineligible relapsed and refractory diffuse large B-cell lymphoma.

Author

Paszkiewicz-Kozik E, Michalski W, Taszner M, Mordak-Domagała M, Romejko-Jarosińska J, Knopińska-Posłuszny W, Najda J, Borawska A, Chełstowska M, Świerkowska M, Dąbrowska-Iwanicka A, Malenda A, Druzd-Sitek A, Konecki R, Kumiega B, Osowiecki M, Ostrowska B, Szpila T, Szymański M, Targoński Ł, Domańska-Czyż K, Popławska L, Giebel S, Lange A, Pluta A, Zaucha JM, Rymkiewicz G, and Walewski J

Subjects
Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cytarabine adverse effects, Etoposide adverse effects, Humans, Ifosfamide, Middle Aged, Neoplasm Recurrence, Local pathology, Rituximab, Salvage Therapy, Lymphoma, Large B-Cell, Diffuse pathology, Lymphoma, Non-Hodgkin etiology
Abstract

The efficacy of salvage treatment of diffuse large B-cell lymphoma (DLBCL) patients who relapse or progress (rrDLBCL) after initial therapy is limited. Efficacy and safety of ofatumumab with iphosphamide, etoposide and cytarabine (O-IVAC) was evaluated in a single-arm study. Dosing was modified for elderly patients. Patients received up to six cycles of treatment. The primary end-point was the overall response rate (ORR). Patients were evaluated every two cycles and then six and 12 months after treatment. Other end-points included progression-free survival (PFS), event-free survival (EFS), overall survival (OS) and safety. Seventy-seven patients received salvage treatment with O-IVAC. The average age was 56.8 years; 39% had an Eastern Cooperative Oncology Group (ECOG) performance status of at least 3; 78% had disease of Ann Arbor stage 3 or 4; 58% received one or more prior salvage therapies. The ORR for O-IVAC was 54.5%. The median duration of study follow-up was 70 months. The median PFS and EFS were 16.3 months each. The median OS was 22.7 months. Age, ECOG performance status and the number of prior therapy lines were independent predictors of survival. Treatment-related mortality was 15.5%. O-IVAC showed a high response rate in a difficult-to-treat population and is an attractive treatment to bridge to potentially curative therapies., (© 2022 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)

Published
2022
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16. In Silico Designed Gain-of-Function Variants of Complement C2 Support Cytocidal Activity of Anticancer Monoclonal Antibodies.

Author

Urban A, Majeranowski A, Stasiłojć G, Koszałka P, Felberg A, Taszner M, Zaucha JM, and Okrój M

Abstract

The molecular target for the classical complement pathway (CP) is defined by surface-bound immunoglobulins. Therefore, numerous anticancer monoclonal antibodies (mAbs) exploit the CP as their effector mechanism. Conversely, the alternative complement pathway (AP) is spontaneously induced on the host and microbial surfaces, but complement inhibitors on host cells prevent its downstream processing. Gain-of-function (GoF) mutations in the AP components that oppose physiological regulation directly predispose carriers to autoimmune/inflammatory diseases. Based on the homology between AP and CP components, we modified the CP component C2 so that it emulates the known pathogenic mutations in the AP component, factor B. By using tumor cell lines and patient-derived leukemic cells along with a set of clinically approved immunotherapeutics, we showed that the supplementation of serum with recombinant GoF C2 variants not only enhances the cytocidal effect of type I anti-CD20 mAbs rituximab and ofatumumab, but also lowers the threshold of mAbs necessary for the efficient lysis of tumor cells and efficiently exploits the leftovers of the drug accumulated in patients' sera after the previous infusion. Moreover, we demonstrate that GoF C2 acts in concert with other therapeutic mAbs, such as type II anti-CD20, anti-CD22, and anti-CD38 specimens, for overcoming cancer cells resistance to complement attack.

Published
2022
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18. High efficacy of BGD (bendamustine, gemcitabine, and dexamethasone) in relapsed/refractory Hodgkin Lymphoma.

Author

Swoboda R, Giebel S, Knopińska-Posłuszny W, Chmielowska E, Drozd-Sokołowska J, Paszkiewicz-Kozik E, Kulikowski W, Taszner M, Mendrek W, Najda J, Czerw T, Olszewska-Szopa M, Czyż A, Giza A, Spychałowicz W, Subocz E, Szwedyk P, Krzywon A, Wilk A, and Zaucha JM

Subjects
Adult, Aged, Aged, 80 and over, Allografts, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bendamustine Hydrochloride administration & dosage, Bendamustine Hydrochloride adverse effects, Combined Modality Therapy, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Dexamethasone administration & dosage, Dexamethasone adverse effects, Drug Evaluation, Female, Hematologic Diseases chemically induced, Hematopoietic Stem Cell Transplantation, Hodgkin Disease radiotherapy, Hodgkin Disease therapy, Humans, Infections etiology, Kaplan-Meier Estimate, Male, Middle Aged, Progression-Free Survival, Radiotherapy, Adjuvant, Recurrence, Retrospective Studies, Transplantation, Autologous, Young Adult, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Hodgkin Disease drug therapy, Salvage Therapy
Abstract

The optimal salvage therapy in relapsed/refractory Hodgkin lymphoma (R/R HL) has not been defined so far. The goal of this multicenter retrospective study was to evaluate efficacy and safety of BGD (bendamustine, gemcitabine, dexamethasone) as a second or subsequent line of therapy in classical R/R HL. We have evaluated 92 consecutive R/R HL patients treated with BGD. Median age was 34.5 (19-82) years. Fifty-eight patients (63%) had received 2 or more lines of chemotherapy, 32 patients (34.8%) radiotherapy, and 21 patients (22.8%) an autologous hematopoietic stem cell transplantation (autoHCT). Forty-four patients (47.8%) were resistant to first line of chemotherapy. BGD therapy consisted of bendamustine 90 mg/m 2 on days 1 and 2, gemcitabine 800 mg/m 2 on days 1 and 4, dexamethasone 40 mg on days 1-4. Median number of BGD cycles was 4 (2-7). The following adverse events ≥ 3 grade were noted: neutropenia (22.8%), thrombocytopenia (20.7%), anemia (15.2%), infections (10.9%), AST/ALT increase (2.2%), and skin rush (1.1%). After BGD therapy, 51 (55.4%) patients achieved complete remission, 23 (25%)-partial response, 7 (7.6%)-stable disease, and 11 (12%) patients experienced progression disease. AutoHCT was conducted in 42 (45.7%) patients after BGD therapy, and allogeneic HCT (alloHCT) in 16 (17.4%) patients. Median progression-free survival was 21 months. BGD is a highly effective, well-tolerated salvage regimen for patients with R/R HL, providing an excellent bridge to auto- or alloHCT.

Published
2021
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19. Genetically determined telomere length and multiple myeloma risk and outcome.

Author

Giaccherini M, Macauda A, Orciuolo E, Rymko M, Gruenpeter K, Dumontet C, Raźny M, Moreno V, Buda G, Beider K, Varkonyi J, Avet-Loiseau H, Martinez-Lopez J, Marques H, Watek M, Sarasquete ME, Andersen V, Karlin L, Suska A, Kruszewski M, Abildgaard N, Dudziński M, Butrym A, Nagler A, Vangsted AJ, Kadar K, Waldemar T, Jamroziak K, Jacobsen SEH, Ebbesen LH, Taszner M, Mazur G, Lesueur F, Pelosini M, Garcia-Sanz R, Jurczyszyn A, Demangel D, Reis RM, Iskierka-Jażdżewska E, Markiewicz M, Gemignani F, Subocz E, Zawirska D, Druzd-Sitek A, Stępień A, Alonso MH, Sainz J, Canzian F, and Campa D

Subjects
Adult, Aged, Female, Genetic Predisposition to Disease, Genome-Wide Association Study, Humans, Male, Middle Aged, Multiple Myeloma diagnosis, Polymorphism, Single Nucleotide, Prognosis, Prospective Studies, Retrospective Studies, Telomere genetics, Multiple Myeloma genetics, Telomere Homeostasis
Abstract

Telomeres are involved in processes like cellular growth, chromosomal stability, and proper segregation to daughter cells. Telomere length measured in leukocytes (LTL) has been investigated in different cancer types, including multiple myeloma (MM). However, LTL measurement is prone to heterogeneity due to sample handling and study design (retrospective vs. prospective). LTL is genetically determined; genome-wide association studies identified 11 SNPs that, combined in a score, can be used as a genetic instrument to measure LTL and evaluate its association with MM risk. This approach has been already successfully attempted in various cancer types but never in MM. We tested the "teloscore" in 2407 MM patients and 1741 controls from the International Multiple Myeloma rESEarch (IMMeNSE) consortium. We observed an increased risk for longer genetically determined telomere length (gdTL) (OR = 1.69; 95% CI 1.36-2.11; P = 2.97 × 10 -6 for highest vs. lowest quintile of the score). Furthermore, in a subset of 1376 MM patients we tested the relationship between the teloscore and MM patients survival, observing a better prognosis for longer gdTL compared with shorter gdTL (HR = 0.93; 95% CI 0.86-0.99; P = 0.049). In conclusion, we report convincing evidence that longer gdTL is a risk marker for MM risk, and that it is potentially involved in increasing MM survival.

Published
2021
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20. Monitoring of the Complement System Status in Patients With B-Cell Malignancies Treated With Rituximab.

Author

Felberg A, Taszner M, Urban A, Majeranowski A, Jaskuła K, Jurkiewicz A, Stasiłojć G, Blom AM, Zaucha JM, and Okrój M

Subjects
Antibodies, Monoclonal, Humanized pharmacology, Antibodies, Monoclonal, Murine-Derived pharmacology, Antigens, CD20 immunology, Antineoplastic Combined Chemotherapy Protocols pharmacology, Cell Line, Tumor, Complement Activation drug effects, Complement Activation immunology, Humans, Lymphoma, Non-Hodgkin drug therapy, Lymphoma, Non-Hodgkin immunology, B-Lymphocytes drug effects, B-Lymphocytes immunology, Complement System Proteins immunology, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy, Leukemia, Lymphocytic, Chronic, B-Cell immunology, Rituximab pharmacology
Abstract

Rituximab is a pioneering anti-CD20 monoclonal antibody that became the first-line drug used in immunotherapy of B-cell malignancies over the last twenty years. Rituximab activates the complement system in vitro , but there is an ongoing debate on the exact role of this effector mechanism in therapeutic effect. Results of both  in vitro  and  in vivo  studies are model-dependent and preclude clear clinical conclusions. Additional confounding factors like complement inhibition by tumor cells, loss of target antigen and complement depletion due to excessively applied immunotherapeutics, intrapersonal variability in the concentration of main complement components and differences in tumor burden all suggest that a personalized approach is the best strategy for optimization of rituximab dosage and therapeutic schedule. Herein we critically review the existing knowledge in support of such concept and present original data on markers of complement activation, complement consumption, and rituximab accumulation in plasma of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphomas (NHL). The increase of markers such as C4d and terminal complement complex (TCC) suggest the strongest complement activation after the first administration of rituximab, but not indicative of clinical outcome in patients receiving rituximab in combination with chemotherapy. Both ELISA and complement-dependent cytotoxicity (CDC) functional assay showed that a substantial number of patients accumulate rituximab to the extent that consecutive infusions do not improve the cytotoxic capacity of their sera. Our data suggest that individual assessment of CDC activity and rituximab concentration in plasma may support clinicians' decisions on further drug infusions, or instead prescribing a therapy with anti-CD20 antibodies like obinutuzumab that more efficiently activate effector mechanisms other than complement., (Copyright © 2020 Felberg, Taszner, Urban, Majeranowski, Jaskuła, Jurkiewicz, Stasiłojć, Blom, Zaucha and Okrój.)

Published
2020
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21. Dual-point FDG-PET/CT for treatment response assessment in Hodgkin lymphoma, when an FDG-avid lesion persists after treatment.

Author

Borra A, Morbelli S, Zwarthoed C, Bianchi A, Bergesio F, Chauvie S, Zaucha JM, Taszner M, Malkowski B, Biggi A, Thyss A, Darcourt J, and Gallamini A

Abstract

FDG-PET/CT (PET) is now considered the standard imaging tool for Hodgkin Lymphoma (HL) staging and restaging. However a CT-detected residual mass at the end of therapy (EoT) is still a challenge for PET interpretation. The aim of our study was to improve the overall accuracy of EoT PET/CT by using a dynamic dual-point scanning at 60 and 120 after FDG injection (2P-PET/CT). Fifty-one HL patients showing a single residual FDG-avid mass (SFAM) at EoT PET/CT were included in the study in Italy and Poland. Treatment was ABVD, ABVD followed by BEACOPP or ABVD plus radiotherapy. Only patients with a SFAM and a Deauville score (DS) > 2 in EoT PET/CT were included in the study. Two independent nuclear medicine reviewed images with a semi-quantitative analysis (SUVMax and retention index, RI) and a visual scoring according to DS. Compared to standard PET, 2P-PET/CT showed only a modest increase in NPV and PPV, from 0.87 to 0.89 and of the PPV from 0.67 to 0.71, respectively. Increase of the overall accuracy became substantial upon including in the analysis only patients whose images were acquired in strict adhesion to original protocol of 2P-PET/CT scanning: (t 120'-6040 min): the sensitivity increased from 0.60 to 1.00, PPV from 0.75 to 0.83 and NPV from 0.89 to 1. This study, with caution for the small number of patients included, seems to suggest that 2P-PET/CT could increase the overall accuracy of EoT PET/CT in correctly classifying treatment response in HL with a persisting SFAM at EoT., Competing Interests: None.

Published
2019

22. Pixantrone, etoposide, bendamustine, rituximab (P[R]EBEN) as an effective salvage regimen for relapsed/refractory aggressive non-Hodgkin lymphoma-Polish Lymphoma Research Group real-life analysis.

Author

Długosz-Danecka M, Hus I, Puła B, Jurczyszyn A, Chojnacki T, Blajer-Olszewska B, Drozd-Sokołowska J, Raźny M, Romejko-Jarosińska J, Taszner M, and Jurczak W

Subjects
Adult, Aged, Disease-Free Survival, Female, Hematopoietic Stem Cell Transplantation methods, Humans, Male, Middle Aged, Neoplasm Recurrence, Local drug therapy, Poland, Recurrence, Retrospective Studies, Salvage Therapy methods, Transplantation, Autologous methods, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bendamustine Hydrochloride therapeutic use, Etoposide therapeutic use, Isoquinolines therapeutic use, Lymphoma, Non-Hodgkin drug therapy, Rituximab therapeutic use
Abstract

Background: Despite a significant improvement in treatment outcomes, 30-40% of aggressive non-Hodgkin lymphomas (NHL) patients are refractory or relapse after the first line therapy. Half of them are not eligible to autologous stem cell transplantation (ASCT) due to failure of platinum-based salvage regimens. Pixantrone is conditionally approved in Europe in patients with R/R aggressive NHL failing at least 2 previous lines of therapy. Polish Lymphoma Research Group (PLRG) evaluated the efficacy and tolerability of P[R]EBEN combining pixantrone, etoposide, bendamustine with or without rituximab), a new regimen developed recently by Francesco d'Amore, in real-life experience., Methods: In this retrospective audit, we analyzed the data of consecutive 25 R/R NHL cases, treated with P[R]EBEN regimen in 9 PLRG centers. Safety and efficacy data, including adverse reactions (AE), response rates, progression-free and overall survival (PFS and OS) were collected., Results: Overall response rate (ORR) to P[R]EBEN regimen was 68% (40% CR and 28% PR). Most patients responded, relatively early, by second cycle of therapy. P[R]EBEN was effective in 8 out of 15 patients (53%) refractory to previous platinum-based salvage regimens. In 4 patients (16%) stabilization of disease (SD) during therapy was observed and further 4 patients (16%) progressed during the treatment (PD). Response rates were higher in patients, chemosensitive to their prior regimen (ORR - 87.5%, including 50% CR). At the median follow-up of 7.5 months (range 1-16) the median PFS and OS were not reached. Projected PFS and OS at 12 months are 68% and 78% respectively. The P[R]EBEN regimen was well tolerated and most of patients received it as out-patients. AEs grade ≥3 occurred in 17 patients (68%). Most common grade 3-4 AEs were due to hematological toxicity with febrile neutropenia observed in 5 patients (20%). There were no episodes of septic deaths. Six patients (24%) died during treatment and follow-up period, all of them due to lymphoma progression., Conclusion: Our data suggest good efficiency and tolerability of P[R]EBEN regimen as a rescue therapy in patients with R/R aggressive NHL., (Copyright © 2019. Published by Elsevier B.V.)

Published
2019
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23. Mutations resulting in the formation of hyperactive complement convertases support cytocidal effect of anti-CD20 immunotherapeutics.

Author

Felberg A, Urban A, Borowska A, Stasiłojć G, Taszner M, Hellmann A, Blom AM, and Okrój M

Subjects
Antibodies, Monoclonal pharmacology, Antibodies, Monoclonal, Humanized, Biomarkers, Cell Line, Tumor, Complement Pathway, Alternative immunology, Complement System Proteins genetics, Complement System Proteins immunology, Cytotoxicity, Immunologic, Gain of Function Mutation, Humans, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy, Leukemia, Lymphocytic, Chronic, B-Cell genetics, Leukemia, Lymphocytic, Chronic, B-Cell metabolism, Leukemia, Lymphocytic, Chronic, B-Cell pathology, Antigens, CD20 metabolism, Antineoplastic Agents, Immunological pharmacology, Complement C3-C5 Convertases genetics, Complement C3-C5 Convertases immunology, Mutation, Rituximab pharmacology
Abstract

Anti-CD20 monoclonal antibodies (mAbs) rituximab and ofatumumab are potent activators of the classical complement pathway, and have been approved for the treatment of B-cell malignancies. However, complement exhaustion and overexpression of complement inhibitors by cancer cells diminish their therapeutic potential. The strategies of targeting membrane complement inhibitors by function-blocking antibodies and the supplementation with fresh frozen plasma have been proposed to overcome tumour cell resistance. We present a novel approach, which utilizes gain-of-function variants of complement factor B (FB), a component of alternative C3/C5 convertases, which augment mAb-activated reactions through a positive feedback mechanism called an amplification loop. If complement concentration is limited, an addition of quadruple gain-of-function FB mutant p.D279G p.F286L p.K323E p.Y363A (or selected single mutants) results in significantly increased complement-mediated lysis of ofatumumab-resistant tumour cells, as well as the complete lysis of moderately sensitive cells. Importantly, this effect cannot be achieved by further increasing ofatumumab concentration. Potentiation of cytotoxic effect towards moderately sensitive cells was less apparent at physiological serum concentration. However, an addition of hyperactive FB could compensate the loss of cytotoxic potential of serum collected from the NHL and CLL patients after infusion of rituximab. Residual levels of rituximab in such sera, in combination with added FB, were able to efficiently lyse tumour cells. We suggest that the administration of gain-of-function variants of FB can restore cytotoxic potential of complement-exhausted serum and maximize the therapeutic effect of circulating anti-CD20 mAbs.

Published
2019
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24. Stem cell mobilization in patients with dialysis-dependent multiple myeloma: Report of the Polish Myeloma Study Group.

Author

Waszczuk-Gajda A, Drozd-Sokołowska J, Boguradzki P, Dybko J, Wróbel T, Basak GW, Mądry K, Snarski E, Charliński G, Frączak E, Matuszkiewicz-Rowińska J, Klinger M, Augustyniak-Bartosik H, Krajewska M, Żebrowski P, Król M, Urbanowska E, Jurczyszyn A, Taszner M, Jędrzejczak WW, and Dwilewicz-Trojaczek J

Subjects
Antigens, CD34 analysis, Female, Hematopoietic Stem Cell Mobilization adverse effects, Humans, Male, Middle Aged, Multiple Myeloma complications, Poland, Renal Dialysis, Retrospective Studies, Transplantation, Autologous, Hematopoietic Stem Cell Mobilization methods, Multiple Myeloma therapy
Abstract

Introduction: High-dose chemotherapy with autologous hematopoietic stem cell transplantation (auto-HSCT) improves the outcome of patients with multiple myeloma (MM). It seems that auto-HSCT is also a feasible therapeutic option in MM dialysis-dependent (MMDD) patients. However, to perform transplantation, a sufficient number of stem cells must be collected., Materials and Methods: Given that data on mobilization of auto-HSC efficacy and safety in dialysis-dependent patients are limited, we report data from all Polish Centers belonging to the Polish Myeloma Study Group. Twenty-eight dialysis-dependent MM-patients were enrolled into this retrospective analysis. The study population comprised patients diagnosed between 2004 and 2015 in whom an attempt to collect auto-HSC was made (68%: women, median age: 56). Patients received granulocyte-colony stimulating factor (G-CSF) alone or in combination with chemotherapy and autologous peripheral blood stem cells (auto-PBSCs) were collected by leukapheresis., Results and Conclusions: The success rate in terms of obtaining sufficient number of CD34(+) cells/kg for an auto-HSCT (≥2 × 10 6 cells/kg body weight) during the first mobilization attempt was 92% (26/28 patients), and for 2 auto-HSCTs (≥4 × 10 6 cells/kg) - was 75% (21/28 patients). After the second mobilization attempt (undertaken in 8 patients), a sufficient number of CD34(+)/kg cells for an auto-HSCT was obtained for all patients and the number of CD34(+)/kg collected cells was sufficient for 2 auto-HSCT in 6 additional patients. Hematologic toxicity and infections were the most frequent complications. Higher doses of cytarabine (>1.6 g/m 2 ) and cyclophosphamide (> 2 g/m 2 ) should be avoided in MMDD patients due to toxicity. Further studies are needed to establish mobilization regimens, confirm their safety, and dosing in MMDD patients., (© 2017 Wiley Periodicals, Inc.)

Published
2018
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25. Autologous transplantation of bone marrow stem cells prepared by the point-of-care system in a patient with myocardial ischemia due to coronary artery chronic total occlusion.

Author

Mielczarek M, Ciecwierz D, Galaska R, Zielinski M, Taszner M, Gruchala M, Raczak G, and Rynkiewicz A

Subjects
Chronic Disease, Humans, Male, Middle Aged, Point-of-Care Systems, Transplantation, Autologous, Bone Marrow Transplantation, Coronary Occlusion complications, Myocardial Ischemia etiology, Myocardial Ischemia surgery, Stem Cell Transplantation
Published
2013
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