Expired Study
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Boston, Massachusetts 02115


Purpose:

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.


Study summary:

- 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.


Criteria:

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


NCT ID:

NCT00146614


Primary Contact:

Principal Investigator
Edwin P. Alyea, MD
Dana-Farber Cancer Institute


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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