BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Completed · Phase 3
Conditions studied: Lymphoma, Non-Hodgkin
In brief
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 facts
- Study ID
- NCT00088530
- Run by
- CTI BioPharma
- People needed
- 140
- Starts
- 2004-07-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2020-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO classification.
- At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
- Relapse after 2 or more prior regimens of chemotherapy
- ECOG performance status of 0, 1, or 2
- Adequate hematologic, renal and hepatic function
- LVEF ≥50% determined by MUGA scan
You may not qualify if…
- Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
- Prior allogenic stem cell transplant
- Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma
- Active CNS lymphoma or HIV-related lymphoma.
- Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization
- Pregnant women or nursing mothers
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- Watson Clinic for Cancer Care and Research — Lakeland, Florida, United States
- Rush University Medical Center — Chicago, Illinois, United States
- New Mexico Oncology/Hematology — Albuquerque, New Mexico, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Northwest Kaiser Permanente — Portland, Oregon, United States
- Northern Utah Hematology Oncology, P.C. — Ogden, Utah, United States
- Clinica Modelo S.A. — Paraná, Entre Ríos Province, Argentina
- Instituto de Investigaciones Clinicas — Rosario, Santa Fe Province, Argentina
- Centro Oncologico Rosario — Rosario, Santa Fe Province, Argentina
- FUNDALEU - fundacion para combatir le Leucernia — Buenos Aires, Argentina
- Hospital Universitario Austral — Buenos Aires, Argentina
- Academia Nacional de Medicina — Caba, Argentina
- Hospital Privado Centro Medico de Cordoba S.A. — Córdoba, Argentina
- ISIS Clinica Especializada — Santa Fe, Argentina
- University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology — Sofia, Bulgaria
- National Centre for Hemotransfusion — Sofia, Bulgaria
- University General Hospital for Active Treatment "St. Marina" Clinic of Hematology — Varna, Bulgaria
- Hospital CIMA San Jose — Escazú, Costa Rica
- Hospital Oncologico de Solca — Capilla Mauta, Guayaquil, Ecuador
- Hospital Carlos Andrade Marin Oncologia — Quito, Pinchincha, Ecuador
- Hospital Solca Quito — Quito, Ecuador
- Tartu University Clinics, Hematology Oncology Clinic — Tartu, Estonia
- Robert A. Moss, M.D., FACP, Inc. — Fountain Valley, California, United States
Full record on ClinicalTrials.gov
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