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

Primary Purpose

Hematologic Malignancies, Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sirolimus

Tacrolimus

About this trial

This is an interventional prevention trial for Hematologic Malignancies focused on measuring Graft versus host disease, GVHD, Stem cell transplantation, sirolimus, tacrolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Institute

Outcomes

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.

Full Information

NCT ID

NCT00144703

First Posted

September 1, 2005

Last Updated

January 24, 2012

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00144703

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Graft versus host disease, GVHD, Stem cell transplantation, sirolimus, tacrolimus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Intervention Type

Drug

Intervention Name(s)

Tacrolimus

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To compare the rates of grade II-IV and III-IV acute GVHD with historical controls

Title

to determine the incidence of 100 day mortality after stem cell transplant using this regimen

Title

to determine the overall survival at 1 year after transplantation in this patient population.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Corey Cutler, MD, MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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