2 In accordance with French regulatory laws, the local ethics committees and the national regulatory agency approved the protocol. We anticipated an ORR rate of 55% and computed that an average sample of 50 patients would provide 80% power at the overall 5% (two-sided) significance level to detect a complete response rate above 40% (null hypothesis: 40%, alternative hypothesis: 55%). The primary endpoint was the overall response rate after completion of four cycles of treatment (ORR). It was deposited on the US National Institutes of Health website ( NCT00169195). This study was an open label, single-arm, multicenter phase II trial. 1 The Lymphoma Study Association (LYSA) conducted a phase II multicenter study to prospectively evaluate the R-GemOx regimen in an homogeneous series of patients with relapsed/refractory DLBCL who were not candidates for high-dose therapy. In a single-center pilot study, the R-GemOx regimen, a combination of rituximab, gemcitabine and oxaliplatin, showed promising activity with an acceptable toxicity profile. Patients with DLBCL who have an early relapse - less than 12 months after ending first-line treatment - or relapse after prior rituximab based-treatment have a poor prognosis. Disease relapse and refractory disease both constitute significant challenges for the treatment of lymphoma, particularly for patients with advanced age or significant comorbidities, who are consequently not candidates for high-dose consolidative therapy. However, some patients are refractory to initial treatment or relapse after achieving a response. The addition of rituximab to conventional chemotherapy has improved response, event-free and overall survival rates in patients with diffuse large B-cell lymphoma (DLBCL). This trial was registered at under # NCT00169195. This therapy can now be considered as a platform for new combinations with targeted treatments. These results are the first confirmation from a multicenter study that rituximab, gemcitabine and oxaliplatin provide a consistent response rate in patients with refractory/relapsed diffuse large B-cell lymphoma. Rituximab, gemcitabine and oxaliplatin were well tolerated with grade 3–4 infectious episodes in 22% of the cycles. Five-year progression-free and overall survival rates were 12.8% and 13.9%, respectively. Factors significantly affecting overall response rate were early (<1 year) progression/relapse (18% versus 54% P=0.001) and prior exposure to rituximab (23% versus 65% P=0.004). After four cycles 21 patients (44%) were in complete remission and 8 (17%) in partial remission, resulting in an overall response rate of 61%. Patients were planned to receive eight cycles if they reached at least partial remission after four cycles. The primary endpoint was overall response rate after four cycles of treatment. International Prognostic Index at enrollment was >2 in 34 patients (71%). Prior treatment included rituximab in 31 (63%) and autologous transplantation in 17 (35%) patients. The median age of the patients was 69 years. This phase II study included 49 patients with refractory (n=6) or relapsing (n=43) diffuse large B-cell lymphoma. We, therefore, conducted a phase II study to determine whether these results could be reproduced in a multi-institutional setting. A previous pilot study with rituximab, gemcitabine and oxaliplatin showed promising activity in patients with refractory/relapsed B-cell lymphoma.
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