Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT00577161
- Lead Sponsor
- CTI BioPharma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator fludarabine and rituximab fludarabine and rituximab Experimental fludarabine, rituximab, pixantrone fludarabine, rituximab, pixantrone
- Primary Outcome Measures
Name Time Method progression-free survival day 64-71
- Secondary Outcome Measures
Name Time Method response rate, survival, safety every 21 days
Trial Locations
- Locations (8)
Northwest Alabama Cancer Center
🇺🇸Muscle Shoals, Alabama, United States
Ventura County Hematology Oncology Specialist
🇺🇸Oxnard, California, United States
Cancer Care Center
🇺🇸Albany, New York, United States
Capitol Comprehensive Cancer Care
🇺🇸Jefferson City, Missouri, United States
Heartland Hematology Oncology Associates
🇺🇸Kansas City, Missouri, United States
Hematology Oncology Consultants
🇺🇸Columbus, Ohio, United States
Interlakes Foundation, Inc.
🇺🇸Rochester, New York, United States
Utah Hematology Oncology, P.C.
🇺🇸Ogden, Utah, United States