Trials / Completed
CompletedNCT00049075
Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- NCIC Clinical Trials Group · Network
- Sex
- All
- Age
- 16 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fludarabine phosphate |
Timeline
- Start date
- 2002-08-08
- Primary completion
- 2005-07-22
- Completion
- 2009-12-21
- First posted
- 2003-01-27
- Last updated
- 2020-04-06
Locations
34 sites across 2 countries: Canada, France
Source: ClinicalTrials.gov record NCT00049075. Inclusion in this directory is not an endorsement.