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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Hodgkin's Disease

Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Hematologic Malignancies

Treatments

Drug: Sirolimus

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00144703

02-090

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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