CFAR Study in Patients With Chronic Lymphocytic Leukemia
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
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).
Second Objectives:
1. 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.
2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the
clonal immunoglobulin heavy chain variable gene in responders treated with CFAR.
3. 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.