Overview

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

Status:
Terminated

Trial end date:
2010-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Genzyme, a Sanofi Company

Treatments:

Antilymphocyte Serum
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Thymoglobulin

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
5. Creatinine
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.