Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509945
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Allogeneic Peripheral Blood Stem Cell Transplantation as the First-line Treatment for Patients With the High-risk Peripheral T Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single-center single-arm prospective phase II clinical trial that evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation in the treatment of high-risk peripheral T-cells lymphoma patients achieved complete response CR or partial response PR Conventional conditioning regimen is adopted while the reduced-intensity conditioning regimens will be preferred Donor hematopoietic stem cell infusion is performed on day 0 All patients will undergo bone marrow examination on day 14 and day 28 post-transplant followed by bone marrow examinations every 30 days within the first year after transplantation and every 60 days within the second year after transplantation Positron emission tomography with 2-deoxy-2-fluorine-18fluoro-D-glucose integrated with computed tomography 18F-FDG PETCT imaging will be performed every 6 months after transplantation If disease relapse is suspected during the follow-up period bone marrow and relapse site examinations will be conducted at any time The primary study endpoints are the 1-year and 2-year progression-free survival PFS rates post-transplant Secondary study endpoints include the incidence of acute graft-versus-host disease GVHD within 180 days post-transplant cumulative relapse rates at 1 year and 2 years post-transplant 1-year and 2-year overall survival OS graft-versus-host disease-free relapse-free survival GRFS non-relapse mortality NRM cumulative incidence of chronic GVHD and the incidence of Cytomegalovirus CMVand Epstein-Barr virusEBVreactivation within 1 year
Detailed Description:
None
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