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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00144703

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 II

MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Tacrolimus Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

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

Study ID Numbers:	02-090
Study First Received:	September 1, 2005
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00144703
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Graft versus host disease
GVHD
Stem cell transplantation
sirolimus
tacrolimus

Study placed in the following topic categories:

Sirolimus
Leukemia, Lymphoid
Hodgkin's disease
Hematologic Neoplasms
Precancerous Conditions
Clotrimazole
Graft versus host disease
Miconazole
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Tacrolimus
Leukemia
Preleukemia
Hodgkin Disease
Lymphoma

Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Tioconazole
Leukemia, Myeloid
Homologous wasting disease
Lymphatic Diseases
Graft vs Host Disease
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Bone Marrow Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Disease
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents

Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Pathologic Processes
Neoplasms by Site
Syndrome
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on January 16, 2009