drugset / Trial / NCT03355768
Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pralatrexate | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 12 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 14 mg/m2 | Intravenous |