Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia|
- Response [ Time Frame: 2 months post consolidation ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 months post consolidation ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2000|
|Study Completion Date:||February 2010|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
Experimental: Fludarabine + Campath-1H
Standard of care induction with fludarabine followed by consolidation antibody therapy
30 mg subQ injection tiw for 6 weeks
Other Name: campath-1HDrug: fludarabine phosphate
25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13
OBJECTIVES: I. Determine the overall response rate of previously untreated patients with stage I, II, III, or IV B-cell chronic lymphocytic leukemia when treated with fludarabine induction followed by alemtuzumab consolidation. II. Determine the infectious toxic effects and feasibility of this regimen in this patient population. III. Determine the treatment-related toxic effects, including infection and injection site reactions, of subcutaneous vs intravenous alemtuzumab in patients treated with this regimen. IV. Determine the progression-free and overall survival of patients treated with this regimen. V. Determine the immunologic effects of this regimen in these patients.
OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week. Treatment repeats every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation. Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months for 1 year and then every 6 months for 8 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004857
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|Study Chair:||Kanti R. Rai, MD||Long Island Jewish Medical Center|