Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00406393
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2006-11-30
Brief Title:
SirolimusTacrolimus Versus TacrolimusMethotrexate for Preventing Graft-Versus-Host Disease GVHD BMT CTN 0402
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A Phase III Randomized Multicenter Trial Comparing SirolimusTacrolimus With TacrolimusMethotrexate as Graft-versus-Host Disease GVHD Prophylaxis After HLA-Matched Related Peripheral Blood Stem Cell Transplantation BMT CTN 0402
Status:
COMPLETED
Status Verified Date:
2022-12
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 study is designed as a phase III randomized open label multicenter prospective comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease GVHD prophylaxis after human leukocyte antigen HLA-matched related peripheral blood stem cell transplantation in individuals with hematologic cancer Participants will be stratified by transplant center and will be randomly assigned to the sirolimustacrolimus or tacrolimusmethotrexate arms at a 11 ratio
Detailed Description:
BACKGROUND
Stem cell transplantation is a standard therapy for acute and chronic leukemias and myelodysplastic disorders A common problem that may occur after a stem cell transplant is a condition known as GVHD The purpose of this study is to compare two combinations of medications to see which is better at preventing GVHD The combinations of medications in this study are
Sirolimus and tacrolimus
Methotrexate and tacrolimus
Doctors want to know if one combination is better than the other or if they both have the same result
DESIGN NARRATIVE
Participants will receive one of the two conditioning regimens described in the protocol at the discretion of the transplant physician The transplant physician must choose among these regimens prior to the participants assignment to the GVHD prophylaxis treatment Conditioning regimens will vary by center but will be the same for all participants at each center Stem cell donors will donate peripheral blood stem cells according to local institutional practices Peripheral blood stem cells will not be manipulated or T-depleted prior to administration Standard post-transplant care will be administered Participants will be randomly assigned to one of two GVHD prophylaxis regimens and will be followed for the endpoints of interest
Participants will be followed for 114 days post-randomization for evaluation of the primary endpoint with additional follow-up for 2 years after transplantation for evaluation of secondary endpoints
Stem cell transplantation is a standard therapy for acute and chronic leukemias and myelodysplastic disorders A common problem that may occur after a stem cell transplant is a condition known as GVHD The purpose of this study is to compare two combinations of medications to see which is better at preventing GVHD The combinations of medications in this study are
Sirolimus and tacrolimus
Methotrexate and tacrolimus
Doctors want to know if one combination is better than the other or if they both have the same result
DESIGN NARRATIVE
Participants will receive one of the two conditioning regimens described in the protocol at the discretion of the transplant physician The transplant physician must choose among these regimens prior to the participants assignment to the GVHD prophylaxis treatment Conditioning regimens will vary by center but will be the same for all participants at each center Stem cell donors will donate peripheral blood stem cells according to local institutional practices Peripheral blood stem cells will not be manipulated or T-depleted prior to administration Standard post-transplant care will be administered Participants will be randomly assigned to one of two GVHD prophylaxis regimens and will be followed for the endpoints of interest
Participants will be followed for 114 days post-randomization for evaluation of the primary endpoint with additional follow-up for 2 years after transplantation for evaluation of secondary endpoints
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL069294-05 | NIH | Blood and Marrow Transplant Clinical Trials Network | httpsreporternihgovquickSearchU01HL069294-05 |
| U01HL069294 | NIH | None | None |
| BMT CTN 0402 | OTHER | None | None |