Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468267
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-11
Brief Title:
RIC With Thiotepa Combined With BuFluAra-C in Allo-HSCT for Relapsed or Refractory PTCL
Sponsor:
Xianmin Song MD
Organization:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Reduced Intensity Conditioning With Thiotepa Combined With Busulfan Fludarabine and Cytarabine in Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed or Refractory 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:
False
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 an reduced-intensity conditioning RIC regimen with thiotepa combined with busulfan fludarabine and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of relapse and refratory peripheral T-cells lymphoma The conditioning regimen includes thiotepa at a dose of 5mgkgd at d -7 1 day fludarabine at 30mgm2d from d -6 to d -2 5 days cytarabine at 1gm2d from d -6 to d -2 5 days and busulfan at 32mgkgd from d -4 to d -3 2 days Conditioning begins on day -7 and 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 FDG-PETCT imaging will be adopted 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None