RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.
OBJECTIVES: * Determine the overall response rate (complete and partial) in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine. * Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug. * Determine the progression-free and treatment-free survival of patients treated with this drug. * Determine the toxicity of this drug in these patients. * Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug. * Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug. * Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug. OUTLINE: This is a multicenter study. Patients receive oral fludarabine on days 1-5. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission after 6 courses do not receive further study therapy. Patients are followed at 2 months and then every 4 months for 2 years. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
128
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