drugset / Trial / NCT03355768

Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL

NCT03355768

RandomizedParallel-groupOpen-labelOther

Summary

This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.

Timeline

Start
2018-09-01
Primary completion
2018-11-01
Completion
2018-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pralatrexate Other / unclassified 25 mg/m2 Intravenous
Subject Romidepsin Peptide 12 mg/m2 Intravenous
Subject Romidepsin Peptide 14 mg/m2 Intravenous