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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Everolimus; Methotrexate; Sirolimus; Tacrolimus

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