Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression
18 Years
N/A
Both
Leukemia
Trial Information
Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression
OBJECTIVES:
Primary
- Compare the effect, in terms of event-free survival, of deferred versus immediate
treatment with rituximab, fludarabine, and cyclophosphamide in patients with previously
untreated Binet stage A chronic lymphocytic leukemia at high risk for disease
progression.
- Investigate and define a new prognostic staging system for patients with Binet stage A
chronic lymphocytic leukemia.
Secondary
- Compare the time to progression to Binet stages B and C in patients treated with these
regimens.
- Compare the overall and progression-free survival of patients treated with these
regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the time to treatment in patients treated with these regimens.
- Analyze the pharmacoeconomics of these regimens in these patients.
- Determine the overall response rate (partial and complete) in patients included in the
early treatment arm.
- For patients included in the early treatment arm in complete remission, determine the
percentage achieving complete molecular remission using the clone-specific CDR-III
region as follow-up parameter.
- Determine the duration of response in patients included in the early treatment arm.
- Determine any adverse events related to treatment/safety of treatment.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk
factor profile (< 2 risk factors [low risk] vs ≥ 2 risk factors [high risk]). Low-risk
patients are assigned to arm II. High-risk patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive rituximab IV on day 1, fludarabine IV on days 1-3, and
cyclophosphamide IV on days 1-3. Treatment repeats every 28 days for up to 6 courses.
- Arm II: Patients undergo observation only until disease progression.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Established diagnosis of B-cell chronic lymphocytic leukemia
- First diagnosis within 12 months before inclusion in study
- Previously untreated disease
- Binet stage A disease (Rai stage 0, I, or II)
PATIENT CHARACTERISTICS:
- Life expectancy > 6 months
- ECOG performance status 0-2
- Willingness to accept contraception (if randomized to arm I) for the duration of
therapy and 12 months thereafter
- Negative serum pregnancy test
- All parameters for risk stratification (lymphocyte doubling time, cytogenetics,
unmutated IgVH, and serum thymidine kinase level > 10) present
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or antibody treatment
- No other concurrent chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Event-free survival
Safety Issue:
No
Principal Investigator
Michael Hallek, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medizinische Universitaetsklinik I at the University of Cologne
Authority:
Unspecified
Study ID:
CDR0000455569
NCT ID:
NCT00275054
Start Date:
October 2005
Completion Date:
Related Keywords:
- Leukemia
- stage 0 chronic lymphocytic leukemia
- B-cell chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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