Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: rituximab; cyclophosphamide; pentostatin
Intervention MeSH terms: Cyclophosphamide; Rituximab; Pentostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: B-cell chronic lymphocytic leukemia; stage I small lymphocytic lymphoma; stage II small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV 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 chronic lymphocytic leukemia.
    

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