At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in High-Risk Previously Untreated Patients With CLL
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine, and 2 other interventions for Leukemia and Chronic Lymphocytic Leukemia. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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