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Sponsored by: |
Cell Therapeutics |
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Information provided by: | Cell Therapeutics |
ClinicalTrials.gov Identifier: | NCT00577161 |
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.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: fludarabine and rituximab Drug: fludarabine, rituximab, pixantrone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Comparator: Active Comparator
fludarabine and rituximab
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Drug: fludarabine and rituximab
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
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Experimental: Experimental
fludarabine, rituximab, pixantrone
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Drug: fludarabine, rituximab, pixantrone
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Alabama | |
Northwest Alabama Cancer Center | |
Muscle Shoals, Alabama, United States, 35661 | |
United States, California | |
Ventura County Hematology Oncology Specialist | |
Oxnard, California, United States, 93030 | |
United States, Missouri | |
Capitol Comprehensive Cancer Care | |
Jefferson City, Missouri, United States, 65109 | |
Heartland Hematology Oncology Associates | |
Kansas City, Missouri, United States, 64118 | |
United States, New York | |
Interlakes Foundation, Inc. | |
Rochester, New York, United States, 14623 | |
Cancer Care Center | |
New Albany, New York, United States, 47150 | |
United States, Ohio | |
Hematology Oncology Consultants | |
Columbus, Ohio, United States, 43235 | |
United States, Utah | |
Utah Hematology Oncology, P.C. | |
Ogden, Utah, United States, 84403 |
Responsible Party: | Cell Therapeutics, Inc ( Igor Gorbatchevsky, Medical Director ) |
Study ID Numbers: | PIX303 |
Study First Received: | December 17, 2007 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00577161 |
Health Authority: | United States: Food and Drug Administration |
pixantrone NHL rituximab fludarabine |
Lymphatic Diseases Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse Fludarabine |
Fludarabine monophosphate Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Antirheumatic Agents |