Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-31 @ 12:15 AM
Study NCT ID:
NCT07074457
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Patients demonstrating disease progression (PD) or stable disease (SD) will be withdrawn from the study.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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: