NCT05931263

A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL

A Randomized Controlled Clinical Trial Comparing Chidamide,Carmustine,Etoposide,Cytarabine and Melphalan With BEAM Regimen Combined With Autologus Hematopoietic Stem Cell Transplantation for the Treatment of Newly Diagnosed PTCL

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL. The main question it aims to answer are: •Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.

Detailed description

This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)

Conditions

• Newly Diagnosed Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	C-BEAM Regimen	Chidemide，carmustine, etoposide, cytarabine, and melphalan
DRUG	BEAM Regimen	carmustine, etoposide, cytarabine, and melphalan

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-02-01
• Completion: 2028-02-01
• First posted: 2023-07-05
• Last updated: 2023-07-05

Locations

1 site across 1 country: China