Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid

Clinical Trial Details

NCT number	NCT00049075
Study type	Interventional
Source	Canadian Cancer Trials Group
Contact
Status	Completed
Phase	Phase 2
Start date	August 8, 2002
Completion date	December 21, 2009

View Details

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