Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00146614

Collaborator

Brigham and Women's Hospital (Other), Beth Israel Deaconess Medical Center (Other), Massachusetts General Hospital (Other)

105

Enrollment

Locations

Duration (Months)

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease Hematologic Malignancies	Drug: Sirolimus Drug: Tacrolimus Drug: Methotrexate Procedure: Stem Cell Transplantation	Phase 2

Detailed Description

Patients will be admitted to the hospital and receive chemotherapy and stem cell transplant(SCT). The total duration of hospitalization for the procedure is approximately 8 days. Once admitted the patient will receive fludarabine daily for 4 days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the patient will receive the infusion of donor cells.
Just prior to the transplant and following the transplant, patients will receive sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy). Methotrexate will be given on days 1,3 and 6 after transplant.
Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
Patients will also receive medication to help prevent possible infection.
After stem cell infusion, patients will be examined and have blood tests weekly for 1 month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow. After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

Study Start Date :

Jul 1, 2002

Actual Primary Completion Date :

Apr 1, 2003

Actual Study Completion Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation.
Donors (both related and unrelated) who are identical at 6 HLA loci.
Age greater than 18
ECOG Performance Status 0-2
Life expectancy of greater than 100 days.

Exclusion Criteria:

Pregnancy
Evidence of HIV infection
Heart failure uncontrolled by medications
Total Bilirubin > 2.0mg/dl due to hepatocellular dysfunction
AST > 90
Serum creatinine > 2.0
Cholesterol > 300 mg/dl

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Isreal Deaconess Medical Center	Boston	Massachusetts	United States	02115
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02115