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

Lymphatic Diseases Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lymphatic Diseases

• NCT number: NCT02497131
• Study type: Interventional
• Source: Fondazione Italiana Linfomi ONLUS
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2015
• Completion date: March 2022