NCT01321541

Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diffuse Large B-cell Lymphoma
• de Novo DLBCL
• DLBCL Transformed From Indolent Lymphoma
• Follicular Grade 3 Lymphoma

Interventions

Type	Name	Description
DRUG	Pixantrone + Rituximab	Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
DRUG	Gemcitabine + Rituximab	Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Timeline

• Start date: 2011-04-20
• Primary completion: 2018-06-28
• Completion: 2018-09-14
• First posted: 2011-03-23
• Last updated: 2021-11-19
• Results posted: 2021-11-19

Locations

131 sites across 17 countries: United States, Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Russia, Slovakia, Spain, Ukraine, United Kingdom