Chronic Lymphocytic Leukemia
Conditions
Keywords
stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
Brief summary
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.
Detailed description
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.
Interventions
DRUGFludarabine 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
DRUGFludarabine
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
Sponsors
German CLL Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL) * Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms * Binet stage A is acceptable, if there are B-symptoms PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 6 months * No severe organ dysfunction * No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia PRIOR CONCURRENT THERAPY: * No prior or concurrent chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 18 Month after end of treatment of the last patient | date of randomization until progression of disease or death of any cause |
| Overall survival | 18 Month after end of treatment of the last patient | Date of randomization until date of death |
| Duration of remission | 18 Month after end of treatment of the last patient | Clinical response was defined according to the guidelines of the NCI-sponsored workshop |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of side effects | 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 | 18 Month after end of treatment of the last patient | EORTC QUOL Questionnaire |
Countries
Austria, Germany
Outcome results
None listed