Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease (GVHD)in patients that have received non-myeloablative peripheral blood stem cell transplantation.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Treatments: Busulfan; Everolimus; Fludarabine; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation

• Availability of a related donor who is identical at 6 HLA loci

• Greater than 18 years of age

• Performance status 0-2

• Life expectancy of > 100 days

Exclusion Criteria:

• Pregnancy

• Evidence of HIV infection

• Heart failure uncontrolled medication

• Total bilirubin > 2.0mg/dl that is due to hepatocellular dysfunction

• AST >90

• Serum Creatinine >2.0

• Cholesterol > 300mg/dl while adequately treated