CFAR Study in Patients With Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00525603|
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : March 4, 2013
Last Update Posted : March 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Chronic Lymphocytic Leukemia||Drug: Cyclophosphamide Drug: Fludarabine Drug: Alemtuzumab Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in High-Risk Previously Untreated Patients With CLL|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
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
20 mg/m^2/day 3-5 IV 5-30 minutes
30 mg Days 1, 3, 5 IV 2-4 hours
375 mg/m^2/day 2 IV 4-6 hours
Other Name: Rituxan®
- Overall Participant Response [ Time Frame: Evaluated after 3 courses of 4 week therapy (12 weeks) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525603
|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|