Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

Detailed Description
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OBJECTIVES: Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only. OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk group are randomized to 1 of 2 treatment arms. Arm I: Patients receive fludarabine. Arm II: Patients undergo observation only. PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.

Official Title
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Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Fludarabine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Confirmed diagnosis of B-cell chronic lymphocytic leukemia Rai stage 0-II (Binet stage A) disease Meets 1 of the following criteria: High-risk disease, as defined by the following: Serum thymidine kinase level > 7.0 U/L Elevated β2-microglobulin level Presence of non-nodular bone marrow infiltration Short lymphocyte doubling time Low-risk disease Meets none of the criteria (as listed above) for high-risk disease PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy More than 6 months Hematopoietic No autoimmune hemolytic anemia No thrombocytopenia Hepatic Not specified Renal Not specified Other No severe organ dysfunction No other prior or concurrent malignancy PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy No other concurrent chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Fludarabine<br> | Drug: Fludarabine<br>* Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles<br>* Other names: Fludura;|
| No Intervention: watch & wait<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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B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia