Clinical trial · Interventional
Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL
Genotype-guided Targeted Agents in Combination With EZH2 Inhibitor, Zeprumetostat for Primary Refractory Peripheral T-cell Lymphoma (PTCL), a Prospective, Open-label, Multi-center Study
NCT07493330CI-TRIAL-00107478not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and efficacy of Zeprumetostat-based combination therapy, selected according to genotyping results, in patients with primary refractory peripheral T-cell lymphoma (PTCL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PTCL | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
| Refractory | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zeprumetostat+Azacitadine | Drug | — | UNRESOLVED |
| Zeprumetostat+Chidamide | Drug | — | UNRESOLVED |
| Zeprumetostat+Decitabine | Drug | — | UNRESOLVED |
| Zeprumetostat+Golidocitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Zeprumetostat+Azacitadine (if with TET2 plus RHOA gene mutation)
- description
- Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Azacitadine :100mg D1-D7, subcutaneous injection, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Azacitidine 100 mg D1-D5, subcutaneous injection for total 3 cycles.
- interventionNames
- Drug: Zeprumetostat+Azacitadine
- type
- EXPERIMENTAL
- label
- Zeprumetostat+Decitabine (if with TP53 gene mutation)
- description
- Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Decitabine 10mg/m2 D1-D5, intravenous infusion, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Decitabine 10mg/m2 D1-D3 for total 3 cycles.
- interventionNames
- Drug: Zeprumetostat+Chidamide
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years, male or female. * Patients with a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) based on 2016 WHO classification * Previously treated with 3 or 6 cycles of a CHOP-like regimen as first-line therapy and considered primary refractory. Patients with anaplastic large cell lymphoma (ALCL) must have adequately received brentuximab vedotin (BV) as part of their first-line treatment. * Tumor tissue genotyping performed and results available prior to enrollment. * ECOG 0, 1, or 2. * Life expectancy greater than 3 months. * Adequate organ function * Contraception during study * Informed consented Exclusion Criteria: * Has a prior malignancy other than the malignancies under study within 3 years without relieve * Primary CNS lymphoma * Known hypersensitivity to any study drug. * Pregnant or lactation * Active infection. * Diseases and medical history: 1. Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers 2. Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 3. Has a history of psychoactive substance abuse that cannot be discontinued 4. Has any severe and/or uncontrolled disease. * Uncontrollable autoimmune disease, * Not able to comply to the protocol for mental or other unknown reasons * Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
References
Publications (0)
Data not yet available
No reference posted for this study.