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NCT Number: NCT07493330

Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL

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).

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Key information

Conditions

PTCL Refractory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

Peripheral T-cell lymphoma (PTCL) is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. Clinical outcomes of refractory patients are even poorer. Targeted drugs are warranted in this group of patients to improve survival. This prospective, multi-center, open-label study will evaluate the efficacy and safety of targeted drug in combination with Zeprumetostat, an EZH2 inhibitor in treatment of primary refractory peripheral peripheral T-cell lymphoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers
  • Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
  • Has a history of psychoactive substance abuse that cannot be discontinued
  • 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.

Treatment and study plan

Zeprumetostat+Azacitadine

Drug

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.

Zeprumetostat+Decitabine

Drug

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.

Zeprumetostat+Chidamide

Drug

Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Chidamide 30 mg biw orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Chidamide 20 mg biw for total 3 cycles.

Zeprumetostat+Golidocitinib

Drug

Zeprumetostat: 350 mg bid, orally, till disease progression (PD) or unacceptable toxicity. Golidocitinib 150 mg qd orally, should ≥2 out of 6 pts experience a DLT, the dose will be adjusted to: Golidocitinib 150 mg qod for total 3 cycles.

Primary outcomes

  1. Summary of DLT events (Phase Ib)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    Measure Description: Enroll 6 pts per cohort and observe the number of pts experiencing dose-limiting toxicity.

  2. Overall response rate (Phase Ⅱ)

    Time frame: At the end of Cycle 3 (each cycle is 28 days)

    Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

Secondary outcomes

  1. Complete response rate

    Time frame: At the end of Cycle 3

    Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

  2. Disease Control Rate

    Time frame: each cycle is 28 days

    Percentage of participants with complete response, partial response, or stable disease, as determined by investigator assessment according to the 2014 Lugano criteria, at the end of Cycle 3

  3. Duration of response

    Time frame: Baseline up to data cut-off

    Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

  4. Duration of complete response

    Time frame: Baseline up to data cut-off

    Time from first occurrence of documented CR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

  5. Progression free survival

    Time frame: Baseline up to data cut-off

    Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

  6. Overall survival

    Time frame: Baseline up to data cut-off

    Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

  7. Treatment-Related Adverse Events

    Time frame: Baseline up to data cut-off

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

  8. Exploratory biomarker analysis

    Time frame: Baseline up to data cut-off

    Exploratory biomarker to predict treatment response and survival

Study contacts

Contact information is provided by the study sponsor or research team.

Pengpeng Xu

CONTACT

[email protected]

Weili Zhao

CONTACT

[email protected]

086-022-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 25, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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