Clinical Trials Logo

Clinical Trial Summary

This study includes Phase I and Phase II stages. Phase I is an open-label trial to confirm RP2D of oral targeted agents in three genetic subtypes. Phase II is a multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.


Clinical Trial Description

Peripheral T-cell lymphoma (PTCL) is a heterogeneous disease with dismal outcomes. Standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) chemotherapy is still the most widely used front-line treatment of PTCL except Brentuximab-CHP application in anaplastic large cell lymphoma (ALCL). The CR rate ranges from 31%-56% in different studies with different PTCL histology compositions. With the exception for ALCL-anaplastic lymphoma kinase (ALK)-positive, the 5-year overall survival (OS) rate is approximately 30%-40% for most subtypes of PTCL patients in current situation, remaining as the unmet medical needs in this disease. Based on genetic subtypes in PTCL, and our previous study exploring targeted agents plus CHOP based on genetic mutations (Guidance-03 study), we conducted this multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus CHOP (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with PTCL. It includes phase I and phase II stages. Patients will receceived stardard CHOP for the first cycle and then obtain the genetic subtypes from tumor NGS befor Cycle 2. In phase I, recommended phase 2 dose (RP2D) of oral targeted agents will be confirmed by traditional "3+3" dose escalation methods. In phase II, patients will receive standard CHOP for the first cycle and then 1:1 be randomized to CHOPX2 or CHOP regimen in each genetic subtypes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05675813
Study type Interventional
Source Ruijin Hospital
Contact Weili Zhao
Phone +862164370045
Email zwl_trial@163.com
Status Recruiting
Phase Phase 1/Phase 2
Start date February 13, 2023
Completion date July 15, 2028

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 NCT05883449 - Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL Phase 2
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
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