An interventional study of Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide) and Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) in CD30+ Peripheral T-cell Lymphoma, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment
To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.
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 Patients demonstrating disease progression (PD) or stable disease (SD) will be withdrawn from the study.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
The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients achieving CR after 3 cycles of BvC therapy will receive 3 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years
Drug: Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide) · Drug: Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) · Drug: Maintenance therapy-chidamide
Patients achieving PR after 3 cycles of BvC therapy will receive 6 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years
Drug: Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide) · Drug: Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) · Drug: Maintenance therapy-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.;
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
Chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years
Complete response rate(CRR)
The rate of patients who achieved CR after 3 cycles of BvC regimen
Time frame: At the end of 3 cycles of BvC (each cycle is 21 days)
Main adverse reactions
The safety and tolerability of the therapeutic regimen measured by the major adverse events.
Time frame: From enrollment to 1 month after consolidation treatment of the last patient
2-year overall survival(OS)
OS will be assessed from the start of the combination regimen to the date of death or end of follow-up.
Time frame: From enrollment to 2 year after treatment of the last patient
Overall response rate(ORR)
The rate of patients who achieved CR or PR after 3 cycles of BvC regimen
Time frame: At the end of 3 cycles of BvC (each cycle is 21 days)
2-year progression-free survival(PFS)
PFS will be assessed from the first drug given to the date of progression, relapse, death or end of follow-up.
Time frame: From enrollment to 2 year after treatment of the last patient
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The First Affiliated Hospital of Soochow University