Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.

Detailed Description
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OBJECTIVES: Determine the overall response rate (complete and partial) in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine. Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug. Determine the progression-free and treatment-free survival of patients treated with this drug. Determine the toxicity of this drug in these patients. Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug. Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug. Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug. OUTLINE: This is a multicenter study. Patients receive oral fludarabine on days 1-5. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission after 6 courses do not receive further study therapy. Patients are followed at 2 months and then every 4 months for 2 years. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.

Official Title
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A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

Conditions
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Leukemia

Intervention / Treatment
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* Drug: fludarabine phosphate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) Previously untreated Rai stage I, II, III, or IV Requiring systemic therapy Persistent lymphocytosis of greater than 5,000/mm^3 Morphologically mature lymphocytes Monoclonal B-cell population CD19/CD5/CD23 positive with kappa or lambda light chain restriction by immunophenotyping No other lymphoproliferative disorders including prolymphocytic leukemia, mantle cell lymphoma, progression to aggressive B-cell lymphoma, or Richter's syndrome No clinical autoimmune hematologic complication of CLL including Coomb's-positive hemolytic anemia or immune thrombocytopenia Positive Coomb's test allowed if no clinical hemolysis PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic See Disease Characteristics Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) AST and/or ALT no greater than 2 times ULN Renal Creatinine no greater than 2 times ULN Other Accessible for treatment and follow-up No known HIV infection No active bacterial, viral, or fungal infection requiring systemic antibiotics No conditions requiring corticosteroid therapy No history of other malignancies except for the following: Adequately treated nonmelanoma skin cancer Curatively treated carcinoma in situ of the cervix Other solid tumors curatively treated with no evidence of disease within the past 5 years No other major medical illness that would preclude study No known hypersensitivity to fludarabine or its components Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy including monoclonal antibody therapy No concurrent autologous or allogeneic stem cell or bone marrow transplantation Chemotherapy No other concurrent cytotoxic drugs Endocrine therapy No concurrent corticosteroids except inhaled or topical corticosteroids No concurrent corticosteroids for nausea prophylaxis Radiotherapy No prior radiotherapy affecting more than 25% of bone marrow and/or involving the pelvic area No concurrent radiotherapy Surgery Not specified Other At least 4 weeks since prior investigational agents No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fludarabine phosphate|nan|

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 I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia