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

Primary Purpose

Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sirolimus
tacrolimus
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myelogenous Leukemia focused on measuring Graft versus Host Disease, GVHD, sirolimus, tacrolimus, Stem cell transplant

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse. Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse. Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase. Myelodysplastic syndromes or myeloproliferative diseases Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure. Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy. Matched unrelated donor. Age 18-55 years at the time of stem cell transplantation ECOG performance status 0-2 Life expectancy of 100 days without stem cell transplantation Total bilirubin < 2.0 mg/dl AST < 90 IU Serum creatinine < 2.0 mg/dl Ejection fraction > 40% by echocardiogram or gated nuclear medicine study. Exclusion Criteria: Uncontrolled infection Forced vital capacity or DLCO < 50% predicted for age Uncontrolled hypertension Prior hematopoietic stem cell transplant Evidence of HIV infection or active Hepatitis B or C infection Cholesterol > 300 mg/dl Relapsed aggressive Burkitt's or Burkitt's-like lymphoma

Sites / Locations

  • Dana-Farber Cancer Center

Outcomes

Primary Outcome Measures

To determine the feasibility of using a combination of 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 control
to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
to determine the overall survival after one year of this patient population.

Full Information

First Posted
September 1, 2005
Last Updated
January 24, 2012
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00144677
Brief Title
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
Official Title
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After HLA-Matched, Unrelated, Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

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 an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
Detailed Description
Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily 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 approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in GVHD. Patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. If GVHD is present, tapering schedule will be slower and based on the patient's clinical condition. Tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus. During the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Non-Hodgkin's Lymphoma, Hodgkin's Disease
Keywords
Graft versus Host Disease, GVHD, sirolimus, tacrolimus, Stem cell transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (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 a combination of 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 control
Title
to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
Title
to determine the overall survival after one year of this patient population.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse. Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse. Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase. Myelodysplastic syndromes or myeloproliferative diseases Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure. Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy. Matched unrelated donor. Age 18-55 years at the time of stem cell transplantation ECOG performance status 0-2 Life expectancy of 100 days without stem cell transplantation Total bilirubin < 2.0 mg/dl AST < 90 IU Serum creatinine < 2.0 mg/dl Ejection fraction > 40% by echocardiogram or gated nuclear medicine study. Exclusion Criteria: Uncontrolled infection Forced vital capacity or DLCO < 50% predicted for age Uncontrolled hypertension Prior hematopoietic stem cell transplant Evidence of HIV infection or active Hepatitis B or C infection Cholesterol > 300 mg/dl Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
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 Center
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 Un-Related Stem Cell Transplantation

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