Gemcitabine in Treating Patients With Recurrent 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 gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Gemcitabine for Relapsed B-Cell Chronic Lymphocytic Leukemia|
|Study Start Date:||February 2000|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the rate and duration of complete and partial remission in patients with recurrent B-cell chronic lymphocytic leukemia treated with gemcitabine. II. Assess the toxicities of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-12 months.
|Study Chair:||Timothy G. Call, MD||Mayo Clinic|