Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00049075|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: fludarabine phosphate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia|
|Actual Study Start Date :||August 8, 2002|
|Actual Primary Completion Date :||July 22, 2005|
|Actual Study Completion Date :||December 21, 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049075
|Study Chair:||Ralph M. Meyer, MD, FRCPC||Margaret and Charles Juravinski Cancer Centre|