Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from a related donor.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with hematologic malignancies who will undergo allogeneic HSCT from matched family-members.

• Age greater than 18

• ECOG performance status 0-2

• Total bilirubin < 2.0 mg/dl

• AST < 90 IU

• Serum creatinine < 2.0 mg/dl

Exclusion Criteria:

• Active, uncontrolled infection

• Ejection fraction < 45% by echocardiogram or MUGA scan

• Forced vital capacity < 60%

• Uncontrolled hypertension

• Second transplantation

• Evidence of HIV infection

• Cholesterol > 300 mg/dl

• Relapsed aggressive Burkitt's or Burkitt's-like lymphoma