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Study 2 of 236 for search of: | chronic lymphocytic leukemia AND Phase III | Open Studies |
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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00513747 |
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with rituximab may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving fludarabine together with rituximab early is more effective than giving fludarabine and rituximab after observation in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how well they work when given early or after observation in treating patients with previously untreated chronic lymphocytic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Biological: rituximab Drug: fludarabine phosphate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III Intergroup CLL Study of Asymptomatic Patients With Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation With Later Treatment in the High Risk Genetic Subset With IGVH Unmutated Disease |
Estimated Enrollment: | 1750 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive rituximab IV over 4 hours on days 1, 3, and 5 of week 1 and then on day 1 of weeks 5, 9, 13, 17, and 21. Patients also receive fludarabine phosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
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Biological: rituximab
Given IV over 4 hours
Drug: fludarabine phosphate
Given IV over 30 minutes
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Arm II: Active Comparator
Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in arm I. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
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Biological: rituximab
Given IV over 4 hours
Drug: fludarabine phosphate
Given IV over 30 minutes
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Genetically high-risk disease: Patients are stratified according to age (< 50 years vs 50 to 70 years vs > 70 years) and presence of the high-risk genetic feature [del(11)(q22.3) or del(17)(p13.1)] by FISH (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients undergo blood sample collection periodically for correlative studies.
After finishing treatment, patients are followed periodically for up to 25 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinical and immunophenotypic evidence of B-cell chronic lymphocytic leukemia (CLL) diagnosed within the past 6 months AND meets the following criteria:
Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers
No evidence of active or progressive disease as demonstrated by any of the following:
Must have undergone IgV_H mutation testing and be classified according to the following:
Genetically low-risk disease
Genetically high-risk disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | John C. Byrd, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000537685, CALGB-10501 |
Study First Received: | August 8, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00513747 |
Health Authority: | Unspecified |
B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Rituximab |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Fludarabine Fludarabine monophosphate Lymphoproliferative Disorders Leukemia, B-Cell |
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 |