Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00276848|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : May 23, 2019
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Fludarabine plus Cyclophosphamide Drug: Fludarabine||Phase 3|
- Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide.
- Compare the incidence of side effects and quality of life of patients treated with these drugs.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms
- Arm I: Patients receive fludarabine IV on days 1-5.
- Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||July 2003|
|Actual Study Completion Date :||July 2007|
|Active Comparator: Fludarabine plus Cyclophosphamide||
Drug: Fludarabine plus Cyclophosphamide
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses
|Active Comparator: Fludarabine||
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses
- Progression-free survival [ Time Frame: 18 Month after end of treatment of the last patient ]date of randomization until progression of disease or death of any cause
- Overall survival [ Time Frame: 18 Month after end of treatment of the last patient ]Date of randomization until date of death
- Duration of remission [ Time Frame: 18 Month after end of treatment of the last patient ]Clinical response was defined according to the guidelines of the NCI-sponsored workshop
- Incidence of side effects [ Time Frame: up to 28 days after the last dose of study medication ]Toxic effects of treatment were evaluated according to the Common Toxicity Criteria (CTC 1.0)
- Quality of life [ Time Frame: 18 Month after end of treatment of the last patient ]EORTC QUOL Questionnaire
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): NCT00276848
|Study Chair:||Michael Hallek, MD||Medizinische Universitaetsklinik I at the University of Cologne|