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RECRUITING
NCT07074457
NA

Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

47

Start Date

2024-11-01

Completion Date

2028-11-01

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

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

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China