drugset / Trial / NCT03349333

A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL

NCT03349333

Phase 3 Completed 85 enrolled Mundipharma (China) Pharmaceutical Co. Ltd
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, open-label, multi-center study designed to demonstrate the efficacy and safety of pralatrexate when administered concurrently with vitamin B12 and folic acid supplementation to patients with relapsed or refractory peripheral T-cell lymphoma(PTCL).

Timeline

Start
2015-09-10
Primary completion
2017-07-21
Completion
2018-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Pralatrexate Other / unclassified 30 mg/m2 Intravenous