A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Alemtuzumab; Rituximab
Intervention description: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks; Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks
Intervention MeSH terms: Rituximab; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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 of giving alemtuzumab together with
      rituximab and to see how well it works in treating patients with previously untreated B-cell
      chronic lymphocytic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following
             criteria:

               -  Peripheral blood absolute lymphocyte count > 5,000/mm³

               -  Small- to moderate-size lymphocytes with < 55% prolymphocytes, atypical
                  lymphocytes, or lymphoblasts

               -  Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the
                  following:

                    -  Predominant population of cells share B-cell antigens with CD-5 in the
                       absence of other pan-T-cell markers (e.g., CD-3, CD-2)

                    -  B-cell expresses either lambda or kappa light chains

                    -  Surface immunoglobulin with low-cell surface density expression NOTE:
                       *Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required
                       for the diagnosis of CLL

          -  Requires therapy, as indicated by ≥ 1 of the following criteria:

               -  Unintentional weight loss > 10% within the past 6 months

               -  Extreme fatigue (i.e., ECOG performance status 2)

               -  Fevers > 100.5°F for 2 weeks without evidence of infection

               -  Night sweats without evidence of infection

               -  Evidence of progressive marrow failure as manifested by the development of or
                  worsening of anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelet
                  count < 100,000/mm³)

               -  Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly

               -  Massive nodes/clusters (> 5 cm), progressive symptomatic adenopathy, or
                  adenopathy resulting in end-organ damage

               -  Progressive lymphocytosis with an increase of > 50% over 2 months or an
                  anticipated doubling time < 6 months

          -  Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence
             of any of the above criteria for active disease is not sufficient for eligibility

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  ANC ≥ 1,000/mm³*

          -  Platelet count ≥ 50,000/mm³*

          -  Hemoglobin ≥ 10 g/dL*

          -  Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance > 40 mL/min

          -  Bilirubin < 2 mg/dL

          -  AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study treatment

          -  No active autoimmune anemia or thrombocytopenia

          -  No active infection requiring oral or intravenous antibiotics

          -  No second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma
             of the cervix, unless curatively treated ≥ 2 years ago NOTE: *If cytopenias are due to
             degree of bone marrow involvement, patient may be eligible at the discretion of the
             principal investigator.

        PRIOR CONCURRENT THERAPY:

          -  Prior corticosteroid therapy allowed

          -  No prior cytotoxic therapy (other than corticosteroids)