Alemtuzumab + Rituximab Consolidation in CLL
Condition: Chronic Lymphocytic Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Alemtuzumab
Intervention description: 375 mg/m^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.; Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13).
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: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Leukemia; CLL; PLL; SLL; Rituximab; Rituxan; Alemtuzumab; Campath

Summary:

      The goal of this clinical research study is to find out how well Campath (alemtuzumab),
      Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia
      (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with CLL, CLL/prolymphocytic leukemia (PLL), or Small Lymphocytic Lymphoma
             (SLL) who have achieved an National Cancer Institute-Working Group (NCI-WG) nodular
             partial (nPR) or complete response (CR) with documentation of residual disease by MRD
             flow cytometry following chemotherapy or chemoimmunotherapy.

          -  Patients with CLL, CLL/PLL, or SLL who have achieved an NCI-WG partial response (PR)
             following prior chemotherapy or chemoimmunotherapy.

          -  Age >/=18 years.

          -  ECOG performance status </=2.

          -  Serum creatinine </= 2 mg/dL; serum total bilirubin </= 2 mg/dL; serum AST or ALT <4 x
             ULN.

          -  Signed informed consent.

          -  Male and female patients who are fertile agree to use an effective barrier method of
             birth control (ie, latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy.
             Female patients of childbearing potential (non-childbearing is defined as >/= 1 year
             post-menopausal or surgically sterilized) need a negative serum or urine pregnancy
             test within 14 days of study enrollment.

        Exclusion Criteria:

          -  Past history of anaphylaxis following exposure to rat or mouse derived complementarity
             determining region (CDR)-grafted humanized monoclonal antibodies.

          -  Hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is
             permitted.

          -  Active Hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, IgM
             anti-HBc, HBV DNA).

          -  Previous treatment with alemtuzumab plus rituximab in combination.

          -  Pregnant or nursing women.

          -  History of HIV infection.

          -  Active uncontrolled infection (defined as exhibiting ongoing signs/symptoms related to
             the infection and without improvement, despite appropriate antibiotics or other
             treatment).

          -  Less than 6 months from the completion of prior chemotherapy or chemoimmunotherapy.
             Completion of prior chemoimmunotherapy is defined as the last day of therapy of the
             respective treatment regimen.

          -  Symptomatic CNS disease.