Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)
Condition: Hematological Malignancies; Myelodysplastic Syndrome; Leukemia; Lymphoma
MeSH terms: Neoplasms; Preleukemia; Hematologic Neoplasms; Myelodysplastic Syndromes
Intervention: Mycophenolate Mofetil (MMF); Thymoglobulin; Sirolimus; Stem Cell Transplant
Intervention description: 15 mg/kg by vein or by mouth every 12 hours.; 1.5 mg/kg by vein daily for 4 days; 6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day.; Stem cell infusion on Day 0.
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hematological Malignancies; Myelodysplastic Syndrome; Graft Versus Host Disease; GVHD; Allogeneic Hematopoietic Stem Cell Transplantation; AHSCT; Leukemia; Lymphoma; T-Cells; Thymoglobulin; ATG; rATG; Rabbit Antithymocyte Globulin; Rapamune; Sirolimus; Mycophenolate Mofetil; Cellcept; MMF

Summary:

      The goal of this clinical research study is to learn if the combination of rabbit
      anti-thymocyte globulin (Thymoglobulin®), sirolimus (Rapamune®), and mycophenolate mofetil
      (Cellcept®) can help to prevent graft versus host disease (GVHD). The safety of this drug
      combination will also be studied.

      Primary Objective: To determine efficacy and toxicity of a regimen of thymoglobulin,
      sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell
      transplantation from human leukocyte antigen (HLA) identical related or unrelated donors.

      Secondary Objective: To assess engraftment, chronic GVHD, relapse and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with high risk hematological malignancies, including those with induction
             failure and after treated or untreated relapse. High risk hematological malignancies
             include: Acute myelogenous or lymphocytic leukemia with induction failure of after
             relapse, myelodysplastic syndrome of intermediate and high risk according to Greenberg
             criteria, chronic myelogenous leukemia in accelerated phase or blast crisis,
             non-Hodgkin's and Hodgkin's lymphoma with induction failure or relapse after
             chemotherapy and refractory or relapsed chronic lymphocytic leukemia.

          2. HLA-identical sibling or matched unrelated donor transplants not eligible for
             protocols of higher priority.

          3. Age 18-75 years.

          4. Bilirubin </=1.5 mg/dl, serum glutamic-pyruvic transaminase (SGPT) </= 200 IU/ml.

          5. Creatinine </=1.6 mg/dl.

        Exclusion Criteria:

          1. Regimens including rituximab or alemtuzumab in the preparative regimen.

          2. Patients can not have received prior treatment with gemtuzumab.

          3. Planned conditioning chemotherapy for transplant can not include gemtuzumab.

          4. Planned conditioning chemotherapy for transplant can not include the busulfan and
             cyclophosphamide regimen.

          5. HIV seropositivity

          6. Uncontrolled infection, not responding to adequate antimicrobial therapy after 7 days
             of treatment. The protocol PI is the final arbiter of eligibility.

          7. Pregnancy

          8. Inability to sign consent.

          9. Patients who are past recipients of allogeneic or autologous stem cell transplants
             from any source.