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Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute GVHD Following Allogeneic Hematopoietic Stem Cell Transplantation


Phase 2
18 Years
75 Years
Not Enrolling
Both
Hematological Malignancies, Myelodysplastic Syndrome, Leukemia, Lymphoma

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Trial Information

Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute GVHD Following Allogeneic Hematopoietic Stem Cell Transplantation


Rabbit anti-thymocyte globulin (rATG), sirolimus, and mycophenolate mofetil (MMF) are all
designed to prevent GVHD.

If you are found to be eligible to take part in this study, you will receive rATG through a
needle in your vein over 3-4 hours on each of the 4 days before the stem cell transplant.

Beginning 2 days before the transplant, you will take sirolimus by mouth once per day. You
will continue to receive sirolimus until 90 days after the transplant. Beginning on Day 60,
you will start taking increasingly lower doses of the study drug. This is done so you can
taper down slowly, and be off of the drug on Day 90.

Beginning on the day of the transplant, you will take MMF by mouth 2 times a day. You will
continue to take MMF until 27 days after the transplant.

Every week (for the first 90-100 days after the transplant) you will have study visits. At
this visit, you will have a physical exam. Blood (about 1-2 tablespoons) will be drawn for
routine tests.

You will remain on study for up to 90 days after transplantation. You will be taken off
study if intolerable side effects occur.

Starting on Day 90 after the transplant, you will continue to follow up with your transplant
doctor at least every 3 months through 1 year after the transplant. During these visits you
will have physical exams. Blood (about 1-2 tablespoons) will be drawn for routine tests.
Your doctor may request additional testing.

This is an investigational study. RATG, sirolimus, and MMF are all FDA approved for their
use in the transplantation of solid organs (like kidney and liver). All 3 drugs are
commercially available. This particular combination and dose schedule is considered
investigational. Up to 30 patients will take part in this study. All will be enrolled at
M.D. Anderson.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Failure Rate

Outcome Description:

Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).

Outcome Time Frame:

Baseline to 100 days post transplant

Safety Issue:

Yes

Principal Investigator

Amin Alousi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0435

NCT ID:

NCT00506948

Start Date:

September 2006

Completion Date:

October 2010

Related Keywords:

  • Hematological Malignancies
  • Myelodysplastic Syndrome
  • Leukemia
  • Lymphoma
  • 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
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030