Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: alemtuzumab; rituximab
Intervention description: Given IV; Given IV
Intervention MeSH terms: Rituximab; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: chronic lymphocytic leukemia; small lymphocytic lymphoma; CLL; elderly; low dose rituximab; alemtuzumab; monoclonal antibodies

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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 rituximab
      together with alemtuzumab may kill more cancer cells.

      PURPOSE: This randomized phase II trial is studying two different doses of rituximab to
      compare how well they work when given together with alemtuzumab in treating older patients
      with progressive chronic lymphocytic leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:

               -  Minimum threshold peripheral lymphocyte count of 5 x 10^9/L (CLL variant) OR
                  palpable adenopathy > 1 cm or palpable splenomegaly 9small lymphocytic lymphoma
                  [SLL] variant)

               -  Immunophenotypic demonstrations of a population of B-lymphocytes (as defined by
                  CD19+) that are monoclonal (by light-chain exclusion) AND have ≥ 3 of the
                  following characteristics:

                    -  CD5+

                    -  CD23+

                    -  Dim surface light chain expression

                    -  Dim surface CD20 expression

               -  FISH analysis is negative for immunoglobulin heavy chain/cyclin D1 gene
                  (IGH/CCND1) and/or immunostaining is negative for cyclin D1 expression (to
                  exclude mantle cell lymphoma)

          -  Progressive, symptomatic CLL, defined by at least one of the following:

               -  Weight loss > 10% within the past 6 months attributable to progressive CLL (grade
                  2 or higher)

               -  Extreme fatigue attributable to progressive CLL (grade 3 or higher)

               -  Fevers > 100.5° F for 2 weeks without evidence of infection (grade 1 or higher)

               -  Night sweats without evidence of infection (drenching)

               -  Evidence of progressive bone marrow failure with hemoglobin < 11 g/dL or platelet
                  count < 100 x 10^9/L

               -  Rapidly progressive lymphadenopathy for which the largest node is ≤ 5 cm in any
                  dimension

                    -  Largest lymph nodes involved in the neck, axilla, and groin need to be
                       measured and followed for response

        Exclusion Criteria:

          -  Prior treatment for CLL

          -  Massive splenomegaly > 6 cm below left costal margin, at rest, on clinical examination

          -  Lymphadenopathy > 5 cm in any diameter

          -  New York Heart Association class III or IV heart disease

          -  Recent myocardial infarction (within the past month)

          -  Uncontrolled infection

          -  Infection with the human immunodeficiency virus (HIV/AIDS)

          -  Serological evidence of active hepatitis B infection (HBsAg or HBeAg positive)

          -  Positive hepatitis C serology

          -  Evidence of active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red
             blood cell aplasia

          -  Other active primary malignancy requiring treatment or that limits survival to ≤ 2
             years, except for in situ carcinoma of the cervix or breast or non-metastatic basal
             cell or squamous cell carcinoma of the skin

          -  Major surgery within 4 weeks prior to pre-registration

          -  Concomitant use of continuous systemic corticosteroids

               -  Prior corticosteroids are allowed but not at time of pre-registration to the
                  study