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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Ventura County Hematology Oncology Specialist
Oxnard, California, United States
Capitol Comprehensive Cancer Care
Jefferson City, Missouri, United States
Heartland Hematology Oncology Associates
progression-free survival
Time frame: day 64-71
response rate, survival, safety
Time frame: every 21 days
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Kansas City, Missouri, United States
Cancer Care Center
Albany, New York, United States
Interlakes Foundation, Inc.
Rochester, New York, United States
Hematology Oncology Consultants
Columbus, Ohio, United States
Utah Hematology Oncology, P.C.
Ogden, Utah, United States