NCT02497131

Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients

Phase II Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30 Positive Peripheral T Cell Lymphoma (PTCL) Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL patients.

Detailed description

BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007). Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) and PET scan will be performed at baseline and Cycles 3, 8, 12, and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Patients with at least stable disease will enter short follow up phase till month 24 with radiology assessment every 6 months and visit every 12 weeks. After month 24 and for all patients with progressive disease, long-term follow-up assessments (including survival, disease status and next therapy information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first.

Conditions

• Lymphatic Diseases

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Brentuximab vedotin will be administered on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg and is administered by outpatient IV infusion given over approximately 30 minutes

Timeline

• Start date: 2015-09-21
• Primary completion: 2019-09-24
• Completion: 2022-03-01
• First posted: 2015-07-14
• Last updated: 2022-03-22

Locations

4 sites across 1 country: Italy