Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)
Condition: Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Lymphoid; Leukemia, Large Granular Lymphocytic; Myelodysplastic Syndromes; Anemia, Aplastic
Intervention: Alemtuzumab
Intervention description: 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Intervention MeSH terms: Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Healthy volunteers: No
Keywords: Hematologic Disorder; Aplastic Anemia; T - Cell Large Granular Lymphocytic Leukemia; T-LGL; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; CLL; Chemotherapy; Alemtuzumab

Summary:

      The goal of this clinical research study is to determine the effectiveness of alemtuzumab in
      patients with aplastic anemia, MDS, or T-Cell large granular lymphocytic leukemia. The safety
      of alemtuzumab will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with the diagnosis of MDS (Low, Int-1 by IPSS, or hypocellular) who are
             either previously untreated or who have been previously treated are eligible for this
             trial.

          2. Patients with the diagnosis of aplastic anemia who have or have not been previously
             treated are eligible for inclusion if they are not currently candidates for an
             allogeneic stem cell transplant.

          3. Patients with the diagnosis of T-LGL who have or have not been previously treated are
             eligible for inclusion.

          4. Patients must have been off of cytotoxic, immunosuppressive, or targeted therapy
             (except hydroxyurea) for at least 2 weeks prior to entering this study, and have
             recovered from the toxic effects of that therapy to grade 1 or less.

          5. Adequate organ function as defined: liver function (bilirubin < or = 2mg/dL, AST
             and/or ALT < or = 3 x ULN) ; kidney function (creatinine < or = 2.5 x ULN ).

          6. ECOG performance status of < or = 3.

          7. The effects of alemtuzumab on the developing human fetus are unknown. For this reason,
             women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately.

          8. A negative urine pregnancy test is required within 1 week for all women of
             childbearing potential prior to enrolling on this trial.

          9. Patient must have the ability to understand the requirements of the study and signed
             informed consent. A signed informed consent by the patient or his legally authorized
             representative is required prior to their enrollment on the protocol.

         10. Patients should have an indication for therapy for their disease such as transfusion
             dependence or morbidity associated with their cytopenia(s) such as bleeding, severe
             fatigue, or frequent/multiple infections (eg. neutropenia).

        Exclusion Criteria:

          1. Pregnant women are excluded from this study because alemtuzumab is an agent with the
             potential for teratogenic or abortifacient effects. Because there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with alemtuzumab, breastfeeding should be discontinued if the mother is treated
             with alemtuzumab. These potential risks may also apply to other agents used in this
             study.

          2. Known HIV infection.

          3. Known Hepatitis B or Hepatitis C infection.

          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          5. Patient with documented hypersensitivity to alemtuzumab.