Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
- Conditions
- Graft Versus Host DiseaseHematologic 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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.
- 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
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.
- Secondary Outcome Measures
Name Time Method
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
Beth Isreal Deaconess Medical Center🇺🇸Boston, Massachusetts, United States