Status:
COMPLETED
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
CTI BioPharma
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00088530
Start Date
July 1 2004
End Date
July 1 2010
Last Update
February 5 2020
Active Locations (99)
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1
Robert A. Moss, M.D., FACP, Inc.
Fountain Valley, California, United States, 92708
2
UCLA Medical Center
Los Angeles, California, United States, 90095
3
Watson Clinic for Cancer Care and Research
Lakeland, Florida, United States, 33805
4
Rush University Medical Center
Chicago, Illinois, United States, 60612