Chronic Lymphocytic Leukemia Clinical Trial
Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Summary
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving pentostatin together with cyclophosphamide and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin together with cyclophosphamide and rituximab works in treating patients with previously untreated leukemia-cll/" >chronic lymphocytic leukemia.
Full Description
OBJECTIVES:
To determine the frequency of response in patients with previously untreated, intermediate- or high-risk B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab.
To characterize the toxicity of this regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course 1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1 year.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL), as evidenced by an absolute lymphocytosis in the blood of at least 5,000 lymphocytes per microliter OR bone marrow lymphocytosis ≥ 30% of all nucleated cells
Previously untreated disease
Meets 1 of the following risk criteria as defined by the three-stage Rai system
Intermediate-risk disease
Must meet the criteria for active disease as defined by the NCI Working Group guidelines including the following:
Weight loss
Fatigue
Fevers
Evidence of progressive marrow failure
Splenomegaly
Progressive lymphadenopathy
Progressive lymphocytosis with a rapid doubling time
High-risk disease
Malignant lymphocytes must demonstrate B-cells via immunophenotypic or immunohistochemical analysis
Patients with small lymphocytic lymphoma (CLL type) are eligible
PATIENT CHARACTERISTICS:
Inclusion criteria:
Karnofsky performance status 60-100%
Total bilirubin ≤ 2.0 mg/dL (patients with Gilbert disease or autoimmune hemolytic anemia should have an evaluation for other causes of hyperbilirubinemia, but if none are found they may be enrolled regardless of serum bilirubin)
Total creatinine ≤ 2.0 mg/dL OR creatinine clearance > 50 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception
Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia are eligible for treatment on this protocol regardless of disease stage
Exclusion criteria:
Significant active infections
Ongoing hepatitis B infection, specifically hepatitis B antigen or surface antigen positivity
Patients who are hepatitis B antibody positive are eligible for this protocol
PRIOR CONCURRENT THERAPY:
Concurrent prednisone allowed provided it is used as brief courses (≤ 7 days) for inflammatory conditions unrelated to CLL
No prior cytotoxic therapy or rituximab for this cancer
No concurrent radiotherapy or other chemotherapy
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There is 1 Location for this study
New York New York, 10065, United States
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