Leukemia Clinical Trial
Official title:
A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-cell CLL
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Alternating treatment with more than one drug may kill more
cancer cells.
PURPOSE: Phase II trial to study the effectiveness of fludarabine alternating with
cyclophosphamide in treating patients who have previously untreated chronic lymphocytic
leukemia.
OBJECTIVES: I. Determine the rate and duration of complete and partial remissions in
patients with previously untreated B-cell chronic lymphocytic leukemia after treatment with
alternating courses of fludarabine and cyclophosphamide. II. Monitor and assess toxicity of
this regimen in these patients. III. Utilize molecular genetic studies and flow cytometry on
peripheral blood cells from patients achieving complete remission by conventional criteria.
IV. Apply FISH techniques using probes to chromosomes 12 and 13 as prognostic factors for
time to progression and overall survival of these patients.
OUTLINE: Patients receive alternating courses of fludarabine and cyclophosphamide.
Fludarabine is administered IV over 10-30 minutes on days 1-5 of courses 1, 3, and 5.
Cyclophosphamide is administered IV over 30-60 minutes on day 1 of courses 2, 4, and 6.
Treatment repeats every 4 weeks. Patients achieving clinical complete remission (CCR) after
6 courses of chemotherapy receive 2 additional courses (one course of each drug). Patients
achieving partial remission after 6 courses of chemotherapy also receive 2 additional
courses. If these patients then achieve CCR, they receive another 2 courses. Patients are
followed every 3 months.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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