NCT00577161

Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL

Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7). This phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	fludarabine and rituximab	days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
DRUG	fludarabine, rituximab, pixantrone	days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2007-12-19
• Last updated: 2020-10-05

Locations

8 sites across 1 country: United States