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.
OBJECTIVES: Primary * 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. Secondary * 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
375
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
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
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria
Hanuschkrankenhaus
Vienna, Austria
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, Germany
Internistische Praxis - Arnstadt
Arnstadt, Germany
Specialist Practice for Oncology
Aschaffenburg, Germany
Progression-free survival
date of randomization until progression of disease or death of any cause
Time frame: 18 Month after end of treatment of the last patient
Overall survival
Date of randomization until date of death
Time frame: 18 Month after end of treatment of the last patient
Duration of remission
Clinical response was defined according to the guidelines of the NCI-sponsored workshop
Time frame: 18 Month after end of treatment of the last patient
Incidence of side effects
Toxic effects of treatment were evaluated according to the Common Toxicity Criteria (CTC 1.0)
Time frame: up to 28 days after the last dose of study medication
Quality of life
EORTC QUOL Questionnaire
Time frame: 18 Month after end of treatment of the last patient
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Klinikum Augsburg
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