Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
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.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia|
|Study Start Date:||August 2002|
|Study Completion Date:||December 2009|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049075
Show 34 Study Locations
|Study Chair:||Ralph M. Meyer, MD, FRCPC||Margaret and Charles Juravinski Cancer Centre|