A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

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.