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Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients
Sponsor: The First Affiliated Hospital of Soochow University
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
Conditions
Interventions
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.;
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
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