CFAR Study in Patients With Chronic Lymphocytic Leukemia
1. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with <5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or sepsis compared to a historic group of patients treated with the combination fludarabine, cyclophosphamide, and rituximab (FCR).
- Assess complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR.
- Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responders treated with CFAR.
- Assess immune parameters including blood T cell counts and subset distribution and serum immunoglobulin levels pretreatment, during treatment, and post-treatment in patients treated with CFAR.
Chronic Lymphocytic Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in High-Risk Previously Untreated Patients With CLL|
- Overall Participant Response [ Time Frame: Evaluated after 3 courses of 4 week therapy (12 weeks) ] [ Designated as safety issue: No ]Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.
|Study Start Date:||June 2005|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
CFAR = Cyclophosphamide 200 mg/m^2/day 3-5 intravenous (IV) 5-30 minutes, Fludarabine 20 mg/m^2/day 3-5 IV 5-30 minutes, Alemtuzumab 30 mg 1, 3,5 IV 2-4 hours, and Rituximab 375 mg/m^2/day 2 IV 4-6 hours
200 mg/m^2/day 3-5 IV 5-30 minutes
Other Names:Drug: Fludarabine
20 mg/m^2/day 3-5 IV 5-30 minutes
Other Names:Drug: Alemtuzumab
30 mg Days 1, 3, 5 IV 2-4 hours
Other Names:Drug: Rituximab
375 mg/m^2/day 2 IV 4-6 hours
Other Name: Rituxan®
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|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||William G. Wierda, M.D., Ph.D.||M.D. Anderson Cancer Center|