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

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

January 24, 2012

Start Date ^ICMJE

July 2002

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00144703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hematologic Malignancies
Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Hodgkin's Disease

Intervention ^ICMJE

Drug: Sirolimus
Drug: Tacrolimus

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00144703

Other Study ID Numbers ^ICMJE

02-090

Has Data Monitoring Committee

Not Provided

Responsible Party

Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Brigham and Women's Hospital

Investigators ^ICMJE

Principal Investigator:

Corey Cutler, MD, MPH

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

January 2009

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

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