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Brief Title: Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
Official Title: Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Study ID: NCT00577161
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, 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