NCT05442554

A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma

A Phase 4, Single Arm, Open Label, Multicenter Study of Brentuximab Vedotin Treatment of Chinese Patients With CD30-Positive Cutaneous T-Cell Lymphoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim is to check the long-term side effects of treatment with Brentuximab Vedotin and to see if that treatment improves symptoms of cluster of differentiation antigen 30 (CD30-Positive) Cutaneous T-Cell Lymphoma in Chinese adults. Participants will receive brentuximab vedotin through the vein on day 1 of each 21 day cycle up to maximum 16 cycles.

Detailed description

The drug being tested in this study is called brentuximab vedotin (SGN-35). Brentuximab vedotin is being tested to treat people who have CD30-positive cutaneous T-Cell lymphoma. The study will enroll approximately 10 patients. Participants will receive a single treatment i.e., brentuximab vedotin monotherapy: • Brentuximab vedotin 1.8 mg/kg Participants will be administered with brentuximab vedotin by intravenous (IV) infusion given for approximately 30 minutes on Day 1 of each 21-day cycle up to 16 cycles followed by the end of treatment (EOT) visit 30 days after receiving the final dose of study drug. Participants with progressive disease (PD) at any time during the study will be discontinued from study drug. This multi-center trial will be conducted in China. Participants will remain in this study for approximately 56 weeks.

Conditions

• T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab vedotin	Brentuximab vedotin IV infusion.

Timeline

• Start date: 2022-11-28
• Primary completion: 2024-08-09
• Completion: 2024-08-09
• First posted: 2022-07-05
• Last updated: 2025-09-18
• Results posted: 2025-08-27

Locations

4 sites across 1 country: China