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

Completed · Phase 2

Conditions studied: Hematologic Malignancies, Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, 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 a related donor.

Key facts

Study ID

NCT00144703

Run by

Dana-Farber Cancer Institute

People needed

55

Starts

2002-07-01

Expected to finish

2006-11-01

Last updated by the study team

2012-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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