T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Condition: Acute Myelogenous Leukemia; Lymphoid Leukemia; Chronic Myelogenous Leukemia; Malignant Lymphoma; Hodgkin's Disease; Chronic Lymphocytic Leukemia; Myeloproliferative Disorder; Anemia, Aplastic; Myelodysplastic Syndromes
MeSH terms: Lymphoma; Leukemia; Preleukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Hodgkin Disease; Myelodysplastic Syndromes; Myeloproliferative Disorders; Anemia, Aplastic
Intervention: Fludarabine; Melphalan; Stem cells; Campath
Intervention description: Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.; Melphalan 140 mg/m2 IV on day -2.; Stem cell infusion on day 0.; Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
Intervention MeSH terms: Fludarabine; Melphalan; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Relapsed or refractory acute myelogenous or lymphoid leukemia.; Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis.; Chronic myelogenous leukemia in chronic phase; Chronic myelogenous leukemia in accelerated phase or blast-crisis; Recurrent or refractory malignant lymphoma or Hodgkin's disease.; Chronic lymphocytic leukemia, relapsed or with poor prognostic features.; Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.; Severe aplastic anemia after failure of immunosuppressive therapy.; Myelodysplastic syndromes (including PNH); Multiple myeloma at high risk for disease recurrence.

Summary:

      Objectives:

        1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and
           non-myelo-ablative ablative stem cell transplantation in patients with hematologic
           malignancies.

        2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based
           in vivo T-cell depletion, in patients with hematologic malignancies undergoing
           non-myelo-ablative stem cell transplantation.

        3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion
           and non-myelo-ablative ablative stem cell transplantation in patients with hematologic
           malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Zubrod performance status 2 (See Appendix B).

          -  Life expectancy is not severely limited by concomitant illness.

          -  Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be
             evaluated by cardiology or pulmonary prior to enrollment on this protocol.

          -  Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .

          -  Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal

          -  No evidence of chronic active hepatitis or cirrhosis.

          -  HIV-negative

          -  Patient is not pregnant

          -  Patient or guardian able to sign informed consent.

        Exclusion Criteria:

          -  N/A