A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant
A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant
The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.
Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods.
Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period.
Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period.
Survival Follow-Up: All patients will be monitored for survival.
Inclusion Criteria:
Exclusion Criteria:
Washington D.C., District of Columbia 20037, United States
Baltimore, Maryland 21237, United States
Innsbruck, 6020, Austria
Sofia, 1431, Bulgaria
Sofia, 1756, Bulgaria
Hradec Králové, 500 05, Czechia
Prague, 128 20, Czechia
Meldola, 47014, Italy
Katowice, 40-032, Poland
Wroclaw, 50-367, Poland
Bucharest, 022328, Romania
Moscow, 105229, Russia
Saint Petersburg, 197758, Russia
Yekaterinburg, 620102, Russia
Banská Bystrica, 975 17, Slovakia
Cherkasy, 18009, Ukraine