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

Phase 2

Completed

• Conditions: Graft Versus Host Disease; Hematologic Malignancies

• Registration Number: NCT00146614
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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 Timeline

• Study Start: 2002-07
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.

Trial Locations

Locations (3)

Beth Isreal Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States