Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
Part of paid clinical trials in Muscle Shoals, Alabama.
- Sponsor
- CTI BioPharma
- Study ID
- NCT00577161
- Phase
- PHASE3
- Status
- Withdrawn
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- fludarabine and rituximab — DRUGdays 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
- fludarabine, rituximab, pixantrone — DRUGdays 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only
Study Details
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.
Key Dates
- Start date
- Sep 30, 2007
- Status verified
- Oct 2020
- Primary completion
- Jul 31, 2012
- Completion
- Jul 31, 2012
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Comparatorfludarabine and rituximab
- Experimental: Experimentalfludarabine, rituximab, pixantrone
Primary Outcome Measure
progression-free survival [ Time Frame: day 64-71 ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwest Alabama Cancer Center | Muscle Shoals | Alabama | 35661 | - |
| Ventura County Hematology Oncology Specialist | Oxnard | California | 93030 | - |
| Capitol Comprehensive Cancer Care | Jefferson City | Missouri | 65109 | - |
| Heartland Hematology Oncology Associates | Kansas City | Missouri | 64118 | - |
| Cancer Care Center | Albany | New York | 12208 | - |
| Interlakes Foundation, Inc. | Rochester | New York | 14623 | - |
| Hematology Oncology Consultants | Columbus | Ohio | 43235 | - |
| Utah Hematology Oncology, P.C. | Ogden | Utah | 84403 | - |
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