Status:
COMPLETED
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Hematologic Malignancies
Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
* Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once per day starting 3 days before stem cell infusion. This will take place in the hospital wher...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00144703
Start Date
July 1 2002
End Date
November 1 2006
Last Update
January 26 2012
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115