Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00004857|
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : July 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: alemtuzumab Drug: fludarabine phosphate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||February 2010|
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-1H
Drug: fludarabine phosphate
25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13
- Response [ Time Frame: 2 months post consolidation ]
- Toxicity [ Time Frame: 2 months post consolidation ]
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): NCT00004857
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|Study Chair:||Kanti R. Rai, MD||Long Island Jewish Medical Center|