Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

This study has been completed.

Sponsor:

Collaborators:

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Information provided by (Responsible Party):

Edwin P. Alyea, MD, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00146614

First received: September 6, 2005

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

March 6, 2012

Start Date ^ICMJE

July 2002

Primary Completion Date

April 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00146614 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

Official Title ^ICMJE

Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

Brief Summary

The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.

Detailed Description

Patients will be admitted to the hospital and receive chemotherapy and stem cell transplant(SCT). The total duration of hospitalization for the procedure is approximately 8 days. Once admitted the patient will receive fludarabine daily for 4 days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the patient will receive the infusion of donor cells.
Just prior to the transplant and following the transplant, patients will receive sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy). Methotrexate will be given on days 1,3 and 6 after transplant.
Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
Patients will also receive medication to help prevent possible infection.
After stem cell infusion, patients will be examined and have blood tests weekly for 1 month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow. After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Graft Versus Host Disease
Hematologic Malignancies

Intervention ^ICMJE

Drug: Sirolimus
Drug: Tacrolimus
Drug: Methotrexate
Procedure: Stem Cell Transplantation

Study Arms

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

105

Completion Date

April 2003

Primary Completion Date

April 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation.
Donors (both related and unrelated) who are identical at 6 HLA loci.
Age greater than 18
ECOG Performance Status 0-2
Life expectancy of greater than 100 days.

Exclusion Criteria:

Pregnancy
Evidence of HIV infection
Heart failure uncontrolled by medications
Total Bilirubin > 2.0mg/dl due to hepatocellular dysfunction
AST > 90
Serum creatinine > 2.0
Cholesterol > 300 mg/dl

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00146614

Other Study ID Numbers ^ICMJE

02-057

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Edwin P. Alyea, MD, Dana-Farber Cancer Institute

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital

Investigators ^ICMJE

Principal Investigator:

Edwin P. Alyea, MD

Dana-Farber Cancer Institute

PRS Account

Dana-Farber Cancer Institute

Verification Date

March 2012

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

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