At a glance
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A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine Phosphate, and 3 other interventions for Stage I Chronic Lymphocytic Leukemia and 3 related conditions. Completed, enrolled 418 participants across 364 sites in 2 countries.
Detailed Summary
This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia.
Study Details
Timeline
Interventions
Given IV
Given IV or PO
Correlative studies
Given PO
Given IV