Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II Lymphoma Study Association trial
Autor: | Nicolas Mounier, Taoufik El Gnaoui, Hervé Tilly, Danièle Canioni, Catherine Sebban, René-Olivier Casasnovas, Richard Delarue, Anne Sonet, Pauline Beaussart, Tony Petrella, Sylvie Castaigne, Serge Bologna, Gilles Salles, Alain Rahmouni, Philippe Gaulard, Corinne Haioun |
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Jazyk: | angličtina |
Rok vydání: | 2013 |
Předmět: | |
Zdroj: | Haematologica, Vol 98, Iss 11 (2013) |
Druh dokumentu: | article |
ISSN: | 0390-6078 1592-8721 |
DOI: | 10.3324/haematol.2013.090597 |
Popis: | A previous pilot study with rituximab, gemcitabine and oxaliplatin showed promising activity in patients with refractory/relapsed B-cell lymphoma. We, therefore, conducted a phase II study to determine whether these results could be reproduced in a multi-institutional setting. This phase II study included 49 patients with refractory (n=6) or relapsing (n=43) diffuse large B-cell lymphoma. The median age of the patients was 69 years. Prior treatment included rituximab in 31 (63%) and autologous transplantation in 17 (35%) patients. International Prognostic Index at enrollment was >2 in 34 patients (71%). The primary endpoint was overall response rate after four cycles of treatment. Patients were planned to receive eight cycles if they reached at least partial remission after four cycles. After four cycles 21 patients (44%) were in complete remission and 8 (17%) in partial remission, resulting in an overall response rate of 61%. Factors significantly affecting overall response rate were early ( |
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