BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Part of paid clinical trials in Fountain Valley, California.
- Sponsor
- CTI BioPharma
- Study ID
- NCT00088530
- Phase
- PHASE3
- Status
- Completed
Conditions
- Lymphoma, Non-Hodgkin
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- pixantrone, cyclophosphamide, vincristine, rituximab, prednisone — DRUGDay 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
- Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab — DRUGDay 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Study Details
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).
Key Dates
- Start date
- Jul 31, 2004
- Status verified
- Jan 2020
- Primary completion
- Feb 28, 2010
- Completion
- Jul 31, 2010
Study Design
- Enrollment
- 140 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental ArmPixantrone (BBR2778)
- Active Comparator: Comparator ArmTo be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
Primary Outcome Measure
Complete Response (CR) and Complete Response Unconfirmed (CRu) [ Time Frame: EOT; approximately 6 months ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Robert A. Moss, M.D., FACP, Inc. | Fountain Valley | California | 92708 | - |
| UCLA Medical Center | Los Angeles | California | 90095 | - |
| Watson Clinic for Cancer Care and Research | Lakeland | Florida | 33805 | - |
| Rush University Medical Center | Chicago | Illinois | 60612 | - |
| New Mexico Oncology/Hematology | Albuquerque | New Mexico | 87109 | - |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | - |
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
| Northwest Kaiser Permanente | Portland | Oregon | 97227 | - |
| Northern Utah Hematology Oncology, P.C. | Ogden | Utah | 84403 | - |
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