Status:
COMPLETED
Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Graft Versus Host Disease
GVHD
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-myeloablati...
Detailed Description
* After the screening procedures confirm that the patient is eligible to participate in the research study, they will be admitted to the hospital to receive chemotherapy and stem cell transplantation ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00282282
Start Date
January 1 2006
End Date
July 1 2009
Last Update
May 12 2014
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115