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Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)

TerminatedPhase 2

Sponsor: M.D. Anderson Cancer Center

Conditions: Hematological Malignancies, Myelodysplastic Syndrome, Leukemia, Lymphoma

Interventions: Mycophenolate Mofetil (MMF), Thymoglobulin, Sirolimus, Stem Cell Transplant

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Houston, Texas, United States