At a glance
ClinicalIndex Comparison Record- ✓Confirmed B-cell chronic lymphocytic leukemia (B-CLL)
- ✓At least one prior therapy received
- ✓Requires treatment for active disease
- ✕Recent anti-cancer therapy (chemotherapy, monoclonal antibodies) within 4 weeks
- ✕History of significant allergic reaction to antibody therapies requiring discontinuation
- ✕HIV positivity
- ✕Active infection requiring treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
In Brief
A Phase 2 clinical trial evaluating Alemtuzumab plus Fludarabine for Leukemia, Lymphocytic, Chronic, B-Cell. Completed, enrolled 60 participants across 27 sites.
Detailed Summary
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.
Study Details
Timeline
Interventions
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days