Clinical trial · Interventional
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
Phase I/IIA Study of the Novel Antifolate Agent Pralatrexate in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Peripheral T-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Why stopped (as posted): Lack of funding and recruitment complications caused by COVID-19
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoid Malignancies | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pralatrexate | Drug | Pralatrexate | ALIAS |
| Romidepsin | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I: Schedule A
- description
- Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 8 of each 21 day cycle
- interventionNames
- Drug: Pralatrexate
- Drug: Romidepsin
- type
- EXPERIMENTAL
- label
- Phase I: Schedule B
- description
- Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 15 of each 28 day cycle
- interventionNames
- Drug: Pralatrexate
- Drug: Romidepsin
- type
- EXPERIMENTAL
- label
- Phase II
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Phase I: Patients must have histologically confirmed relapsed or refractory Non-Hodgkin's lymphoma, Hodgkin's Disease or multiple myeloma (defined by World Health Organization (WHO) criteria). Phase II: Patients must have histologically confirmed relapsed or refractory T-Cell Lymphoma (as defined by WHO criteria). * Must have received first line chemotherapy. No upper limit for the number of prior therapies * Evaluable Disease * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Patients must have adequate organ and marrow function as defined in the protocol * Adequate Contraception * Ability to understand and the willingness to sign a written informed consent document * Inclusion Criteria for Multiple Myeloma patients specified in the protocol Exclusion Criteria: * Prior Therapy * Exposure to chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier * Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs * No other investigational agents are allowed * Central nervous system metastases, including lymphomatous meningitis * History of allergic reactions to Pralatrexate or Romidepsin * Uncontrolled intercurrent illness * Pregnant women * Nursing women * Current malignancy or history of a prior malignancy, as outlined in the protocol * Patient known to be Human Immunodeficiency Virus (HIV)-positive * Active Hepatitis A, Hepatitis B, or Hepatitis C infection
References
Publications (2)
- DERIVEDRyu 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. PMID 38517235
- DERIVEDAmengual 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. PMID 29141948