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

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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2003

- 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.

Intervention(s) in this Clinical Trial

• Drug: Sirolimus
• Drug: Tacrolimus
• Drug: Methotrexate
• Procedure: Stem Cell Transplantation

Primary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dana-Farber Cancer Institute

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00146614

Study ID Number: 02-057

ClinicalTrials.gov Identifier: NCT00146614

Health Authority: United States: Institutional Review Board