Status:
COMPLETED
Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Conditions:
Graft Versus Host Disease
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 me...
Detailed Description
* 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00146614
Start Date
July 1 2002
End Date
April 1 2003
Last Update
March 8 2012
Active Locations (3)
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1
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115