Clinical trial · Interventional
Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL
Randomized Study of Romidepsin Versus the Combination of Romidepsin Plus Pralatrexate in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was never opened due to lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, T-Cell, Peripheral | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pralatrexate | Drug | Pralatrexate | ALIAS |
| Romidepsin | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Romidepsin Arm
- description
- Control Arm: Subjects will receive Romidepsin 14 mg/m2 on Days 1, 8, 15.
- interventionNames
- Drug: Romidepsin
- type
- EXPERIMENTAL
- label
- Romidepsin + Pralatrexate Combination Arm
- description
- Combination Arm: Subjects will receive Romidepsin 12 mg/m2 and Pralatrexate 25 mg/m2.
- interventionNames
- Drug: Romidepsin
- Drug: Pralatrexate
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed relapsed or refractory aggressive peripheral T-cell lymphoma as defined by 2016 World Health Organization (WHO) criteria (excluding nasal natural killer t-cell (NK-T) and blastic natural killer (NK)) * Patients are required to have no more than 5 lines of prior therapy (with cytoreductive therapy followed by autologous stem cell transplant counting as one line of therapy. Patients are eligible if they have relapsed after prior autologous or allogeneic stem cell transplant * Measurable Disease * Age \>18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<2 * Patients must have adequate organ and marrow function * Adequate contraception * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior Therapy * Prior exposure to pralatrexate or a histone deacetylase inhibitor (romidepsin, chidamide, belinostat, or vonrinostat) * Exposure to chemotherapy or radiotherapy within 2 weeks 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 concurrent investigational agents are allowed. * Central nervous system metastases, including lymphomatous meningitis * Uncontrolled intercurrent illness * Pregnant women * Nursing women * Current malignancy or history of a prior malignancy * Patient known to be Human Immunodeficiency Virus (HIV)-positive * Active Hepatitis A, Hepatitis B, or Hepatitis C infection
References
Publications (0)
Data not yet available