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

NCT ID: NCT00144703

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2006-11-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Sirolimus

Intervention Type: DRUG

Tacrolimus

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Corey S. Cutler, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corey Cutler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

02-090

Identifier Type: -

Identifier Source: org_study_id