Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
Condition: Non-Hodgkin's Lymphoma; Leukemia; Multiple Myeloma; Acute Myeloid Leukemia; Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes
Intervention: Thymoglobulin; Total-Body Irradiation; Allogeneic PBSCT or BMT; Tacrolimus; Mycophenolate Mofetil
Intervention description: Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7.; Undergo TBI; Undergo allogeneic PBSCT or BMT; Given PO; Given PO
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: total body irradiation; Allogeneic Peripheral Blood Stem Cell Transplantation; thymoglobulin

Summary:

      One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal
      Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem
      cells to replace the tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with hematological malignancies for which allogeneic stem cell
             transplantation indicated including non-Hodgkin lymphoma (NHL), multiple myeloma (MM),
             acute myeloid leukemia (AML), Hodgkin lymphoma (HD), chronic lymphocytic leukemia
             (CLL), chronic myelogenous leukemia (CML), and myelodysplastic syndrome (MDS)

          -  Patients with HLA compatible related or unrelated stem cell donor, willing and able to
             serve as an allogenic HSC donor. Unrelated donors have to be matched at HLA-A, B, C
             and DRB1 loci. A single locus mismatch will be tolerated in the event a more closely
             matched donor is not available.

          -  Patients age >/=40 to </=70 with an ECOG performance status < 2

          -  Patients between 18 and 40 years of age will be eligible only if they have
             co-morbidities precluding conventional allogeneic transplantation with full intensity
             myeloablative conditioning

          -  Adequate cardiac, pulmonary, renal and hepatic function for transplant

          -  Negative serology for HIV

          -  Negative serum pregnancy test

          -  Patients who have received therapeutic radiation to a localized field will be
             eligible, provided critical structure tolerance doses have not been exceeded

          -  Patients who have had prior myeloablative autologous transplant will be eligible

        Exclusion Criteria:

          -  Evidence of uncontrolled viral, fungal, bacterial infection

          -  Evidence of active meningeal or CNS disease

          -  Prior therapy with rabbit ATG, prior treatment with equine ATG is allowed if more than
             3 months ago

          -  Breast feeding mothers are excluded