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

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00144703
First received: September 1, 2005
Last updated: January 24, 2012
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Hematologic Malignancies
Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Hodgkin's Disease
 Drug: Sirolimus
Drug: Tacrolimus
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 55
Study Start Date: July 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144703

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Corey Cutler, MD, MPH Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Corey S. Cutler, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00144703     History of Changes
Other Study ID Numbers: 02-090
Study First Received: September 1, 2005
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Graft versus host disease
GVHD
Stem cell transplantation
sirolimus
tacrolimus

Additional relevant MeSH terms:
Neoplasms
Graft vs Host Disease
Hodgkin Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Hematologic Neoplasms
Immune System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Sirolimus
Everolimus
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013