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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144703
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : January 26, 2012
Brigham and Women's Hospital
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute

September 1, 2005
September 5, 2005
January 26, 2012
July 2002
November 2006   (Final data collection date for primary outcome measure)
To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
Same as current
Complete list of historical versions of study NCT00144703 on Archive Site
  • To compare the rates of grade II-IV and III-IV acute GVHD with historical controls
  • to determine the incidence of 100 day mortality after stem cell transplant using this regimen
  • to determine the overall survival at 1 year after transplantation in this patient population.
Same as current
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Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation
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.
  • Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once per day starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
  • Sirolimus will continue for 9 weeks at at stable dose, then will be tapered by 1/3 on week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant evidence of GVHD. These dose modifications will occur at home and patients will be seen weekly for the first 2 months after discharge.
  • If GVHD is present, the tapering schedule wil be slower and based upon the patient's clinical condition.
  • Tacrolimus will be given orally once the patient is discharged from the hospital and will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and sirolimus will be monitored and the dose adjusted accordingly.
  • During the year following stem cell transplant, blood work will be performed to evaluate the immune system and GVHD.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Hematologic Malignancies
  • Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Drug: Sirolimus
  • Drug: Tacrolimus
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2006
November 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Corey Cutler, MD, MPH Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP