Status:
COMPLETED
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Acute Myelogenous Leukemia
Graft Versus Host Disease
Eligibility:
All Genders
18-55 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 an unrelated donor. This trial is designed...
Detailed Description
* Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily starting 3 days before stem cell infusion. This will take place in the hospital where ...
Eligibility Criteria
Inclusion
- Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase.
- Myelodysplastic syndromes or myeloproliferative diseases
- Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure.
- Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy.
- Matched unrelated donor.
- Age 18-55 years at the time of stem cell transplantation
- ECOG performance status 0-2
- Life expectancy of 100 days without stem cell transplantation
- Total bilirubin \< 2.0 mg/dl
- AST \< 90 IU
- Serum creatinine \< 2.0 mg/dl
- Ejection fraction \> 40% by echocardiogram or gated nuclear medicine study.
Exclusion
- Uncontrolled infection
- Forced vital capacity or DLCO \< 50% predicted for age
- Uncontrolled hypertension
- Prior hematopoietic stem cell transplant
- Evidence of HIV infection or active Hepatitis B or C infection
- Cholesterol \> 300 mg/dl
- Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00144677
Start Date
November 1 2003
End Date
June 1 2006
Last Update
January 26 2012
Active Locations (1)
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1
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115