Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00049075
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Providence Health Care - Vancouver
🇨🇦Vancouver, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
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