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

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Non-Hodgkin's Lymphoma, Hodgkin's Disease

In brief

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 to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.

Key facts

Study ID

NCT00144677

Run by

Dana-Farber Cancer Institute

People needed

30

Starts

2003-11-01

Expected to finish

2006-06-01

Last updated by the study team

2012-01-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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