drugset / Trial / NCT01947140
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are in patients with lymphoid malignancies and to determine the dose of the combination of drugs that is safest. If the combination is determined to be safe, the study will continue accrual patients with peripheral T-Cell lymphoma (PTCL).
Timeline
- Start
- 2013-09-09
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
Publications
- Ryu Tiger YK, Jain S, Barta SK, Tolu S, Estrella B, Sawas A, Lue JK, Francescone MM, Pro B, Amengual JE. Phase II study of the novel antifolate agent pralatrexate in combination with the histone deacetylase inhibitor romidepsin for the treatment of patients with mature T-cell lymphoma. Leuk Lymphoma. 2024 Jun;65(6):736-745. doi: 10.1080/10428194.2024.2329996. Epub 2024 Mar 22.
- Amengual JE, Lichtenstein R, Lue J, Sawas A, Deng C, Lichtenstein E, Khan K, Atkins L, Rada A, Kim HA, Chiuzan C, Kalac M, Marchi E, Falchi L, Francescone MA, Schwartz L, Cremers S, O'Connor OA. A phase 1 study of romidepsin and pralatrexate reveals marked activity in relapsed and refractory T-cell lymphoma. Blood. 2018 Jan 25;131(4):397-407. doi: 10.1182/blood-2017-09-806737. Epub 2017 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pralatrexate | Other / unclassified | 10 mg/m2 | Intravenous |
| Subject | Pralatrexate | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 12 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 14 mg/m2 | Intravenous |