Clinical Trials Logo
  1. Home
  2. Peripheral T-cell Lymphoma
  3. NCT06468267

Reduced Intensity Conditioning With Thiotepa Combined With Bu/Flu/Ara-C in Allo-HSCT for Relapsed or Refractory Peripheral T-cell Lymphoma.

Peripheral T Cell Lymphoma Clinical Trial

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.

Clinical Trial Summary

This study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with extramedullary involvement. 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. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06468267
Study type Interventional
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact xianmin Song, MD
Phone +86 1350167250
Email shongxm@139.com
Status Recruiting
Phase Phase 2
Start date June 2024
Completion date June 2026
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT04390737 - Evaluate the Safety and Clinical Activity of HH2853 Phase 1/Phase 2
Recruiting NCT05559008 - A Umbrella Study in R/R PTCL Guided by Molecular Subtypes Phase 1/Phase 2
Recruiting NCT06083701 - Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study Phase 1/Phase 2
Not yet recruiting NCT02856997 - Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04083495 - CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma Phase 2
Not yet recruiting NCT05979792 - Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma Early Phase 1
Recruiting NCT04984837 - Study of Lacutamab in Peripheral T-cell Lymphoma Phase 2
Recruiting NCT06072131 - To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL Phase 3
Completed NCT01716806 - A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) Phase 2
Terminated NCT03947255 - A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04028440 - γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Early Phase 1
Not yet recruiting NCT05923502 - (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Recruiting NCT05883449 - Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL Phase 2
Active, not recruiting NCT03586999 - Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas Phase 1/Phase 2
Recruiting NCT04489264 - The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Recruiting NCT06151106 - Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma Phase 2
Recruiting NCT02753543 - Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma Phase 2
Not yet recruiting NCT06089941 - Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas