Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144677
Status:
COMPLETED
Last Update Posted:
2012-01-26
First Post:
2005-09-01
Brief Title:
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None