A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Ralph M. Meyer, MD, FRCPC
Margaret and Charles Juravinski Cancer Centre
United States: Federal Government