Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Alemtuzumab; Rituximab
Intervention description: 30 mg Monday, Wednesday, and Friday x 5 weeks; 375mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Intervention MeSH terms: Rituximab; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; B-cell chronic lymphocytic leukemia

Summary:

      RATIONALE: Monoclonal antibodies, such as alemtuzumab and 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
      alemtuzumab together with rituximab may kill more cancer cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving alemtuzumab
      together with rituximab works in treating patients with high-risk, early-stage chronic
      lymphocytic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        * Diagnosis of B-cell chronic lymphocytic leukemia (CLL)

        - Early-stage, biologically high-risk disease defined by the following criteria:

          -  Rai stage 0-II (does not meet standard NCI-sponsored Working Group criteria for
             treatment)

          -  Clinical and phenotypic features manifested in the peripheral blood, including the
             following:

               -  Minimum threshold peripheral blood lymphocyte count of > 5,000/mm³

               -  Small-to-moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes

               -  Monoclonality of B lymphocytes by immunophenotypic evaluation, demonstrating
                  co-expression of CD19, CD5, and CD23 antigens, surface expression of CD20 and
                  CD52, and B-cell monoclonal population defined by light-chain exclusions

          -  Poor prognosis demonstrated by ≥ 1 of the following high-risk parameters:

               -  Unmutated human immunoglobulin variable region heavy chain (IgVH) gene and CD38
                  expression (≥ 30% cells positive on flow cytometry) OR unmutated IgVH ZAP-70
                  expression (≥ 20% cells positive on flow cytometry) = 11q- = 17p-

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 times ULN

          -  AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)

          -  Hemoglobin ≥ 9.0 g/dL

          -  No New York Heart Association class III-IV heart disease

          -  No myocardial infarction within the past month

          -  No uncontrolled infection

          -  No active HIV infection

          -  No evidence of autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood
             cell aplasia

          -  No other active primary malignancy requiring treatment or limiting survival to less
             than 2 years

        PRIOR CONCURRENT THERAPY:

          -  No prior treatment for CLL

          -  Prior corticosteroids allowed

          -  No prior radiotherapy

          -  More than 4 weeks since prior major surgery