Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, 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 fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.

Detailed Description
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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.

Official Title
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Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Fludarabine
* Drug: Chlorambucil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F<br>Fludarabine | Drug: Fludarabine<br>* Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles<br>|
| Active Comparator: CLB<br>Chlorambucil | Drug: Chlorambucil<br>* Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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