Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
65 Years
79 Years
Both
Leukemia
Trial Information
Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
OBJECTIVES:
Primary
- Compare the overall and progression-free survival of older patients with previously
untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.
- Compare the duration of remission in patients treated with these regimens.
Secondary
- Compare the incidence of toxicity, especially infections, in patients treated with
these regimens.
- Compare the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for
up to 6 courses.
- Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days
for up to 12 months.
PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following
staging criteria:
- Binet stage A with B symptoms
- Binet stage B or C, meeting 1 of the following criteria:
- Rapid disease progression
- Enlarged lymph nodes and organs
- Severe B symptoms
- Previously untreated disease
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- More than 6 months
Hematopoietic
- No thrombocytopenia
- No autoimmune hemolytic anemia
Hepatic
- Not specified
Renal
- Not specified
Other
- No severe organ dysfunction
- No other prior or concurrent neoplasm
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Michael Hallek, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medizinische Universitaetsklinik I at the University of Cologne
Authority:
United States: Federal Government
Study ID:
CDR0000455042
NCT ID:
NCT00262795
Start Date:
September 2003
Completion Date:
Related Keywords:
- Leukemia
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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