NCT07074457

Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients

A Prospective, Exploratory Clinical Study of Chidamide Combined With Brentuximab Vedotin Regimen in the Treatment of CD30 Positive PTCL Patients Unfit for Chemotherapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.

Detailed description

This study will enroll CD30-positive peripheral T-cell lymphoma (PTCL) patients who are ineligible for conventional chemotherapy. Participants will receive induction therapy with 3 cycles of BvC regimen (brentuximab vedotin plus chidamide combination). Patients demonstrating disease progression (PD) or stable disease (SD) will be withdrawn from the study. Patients achieving partial remission(PR) or complete remission(CR) will receive stratification consolidation therapy as followings: Cohort 1 (patients achieved CR): Receive 3 additional cycles of BvC consolidation Cohort 2 (patients achieved PR): Receive 6 additional cycles of BvC consolidation After consolidation therapy, responding patients (CR/PR) will receive chidamide maintenance therapy for ≥2 years

Conditions

• CD30+ Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide)	3 cycles of BvC treatment for all enrolled patients. Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.;
DRUG	Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide)	Consolidation therapy( For patients who achieved CR after induction therapy, 3 cycles of additional BvC treatment; For patients who achieved PR after induction therapy, 6 cycles of additional BvC treatment). Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.; Maintenance therapy chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years
DRUG	Maintenance therapy-chidamide	Chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-08-01
• Completion: 2028-11-01
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: China