drugset / Trial / NCT03496779

Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine

NCT03496779

Phase 2 Completed 71 enrolled The Lymphoma Academic Research Organisation
NaSingle-groupOpen-labelTreatment

Summary

This study is an open label, multicenter phase 2 study. The primary objective of the study is to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

Timeline

Start
2018-04-10
Primary completion
2020-01-31
Completion
2022-10-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg
Background Gemcitabine Small molecule 1000 mg/m2