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Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients

NCT07074457 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-07-20

No results posted yet for this study

Summary

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

Conditions

  • CD30+ Peripheral T-cell Lymphoma

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2028-08-01
Completion
2028-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074457 on ClinicalTrials.gov