RIC With Thiotepa Combined With Bu/Flu/Ara-C in Allo-HSCT for Relapsed or Refractory PTCL.
NCT Number: NCT06468267
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Peripheral T Cell Lymphoma
Interventions: DRUG: Thiotepa
Sponsor: Xianmin Song, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-07-15
Locations: Shanghai General Hospital, Shanghai, Shanghai, 200080, China

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 5mg/kg/d at d -7 (1 day), fludarabine at 30mg/m2/d from d -6 to d -2 (5 days), cytarabine at 1g/m2/d from d -6 to d -2 (5 days), and busulfan at 3.2mg/kg/d 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-PET/CT 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 （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.

Primary Outcome Measures: 1y and 2y-progression-free survival (PFS), 1-year and 2-year progression-free survival (PFS) rates post-transplant, up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS
Secondary Outcome Measures: acute graft-versus-host disease (aGVHD), acute graft-versus-host disease (aGVHD) within 180 days post-transplant, up to 180 days|1y and 2y-cumulative relapse rates (CIR), cumulative relapse rates (CIR) at 1 year and 2 years post-transplant, up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR|1y and 2y-overall survival (OS), overall survival (OS) at 1 year and 2 years post-transplant, up to 1 years for the 1y-OS and up to 2 years for the 2y-OS|graft-versus-host disease-free, relapse-free survival (GRFS), graft-versus-host disease-free, relapse-free survival (GRFS) at 2 years post-transplant, up to 2 years|non-relapse mortality (NRM), non-relapse mortality (NRM) at 2 years post-transplant, up to 2 years|cumulative incidence of chronic GVHD, cumulative incidence of chronic GVHD at 2 years post-transplant, up to 2 years|CMV and EBV reactivation, the incidence of CMV and EBV reactivation within 1 year, up to 1 year