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Clinical Trial NCT07493330 for PTCL, Refractory is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL Phase 1, Phase 2 86 Combination Therapy

Not yet recruiting
Clinical Trial NCT07493330 is designed to study Treatment for PTCL, Refractory. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 23 March 2026 until the study accrues 86 participants. Led by Ruijin Hospital, this study is expected to complete by 12 December 2030. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
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).
Detailed Description
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...Show More
Official 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

Conditions
PTCLRefractory
Other Study IDs
  • Target
NCT ID Number
NCT07493330
Start Date (Actual)
2026-03-23
Last Update Posted
2026-03-25
Completion Date (Estimated)
2030-12-12
Enrollment (Estimated)
86
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Keywords
PTCL
Genotype-guided
Zeprumetostat
Refractory
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalZeprumetostat+Azacitadine (if with TET2 plus RHOA gene mutation)
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+Azacitadine
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.
ExperimentalZeprumetostat+Decitabine (if with TP53 gene mutation)
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
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.
ExperimentalZeprumetostat+Chidamide (if with CREBBP/EP300/KMT2C/KMT2D/NCOR2 gene mutation)
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+Decitabine
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.
ExperimentalZeprumetostat+Golidocitinib (if not above genotype)
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.
Zeprumetostat+Golidocitinib
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Summary of DLT events (Phase Ib)
Measure Description: Enroll 6 pts per cohort and observe the number of pts experiencing dose-limiting toxicity.
At the end of Cycle 1 (each cycle is 28 days)
Overall response rate (Phase Ⅱ)
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
At the end of Cycle 3 (each cycle is 28 days)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
At the end of Cycle 3
Disease Control Rate
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
each cycle is 28 days
Duration of response
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.
Baseline up to data cut-off
Duration of complete response
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.
Baseline up to data cut-off
Progression free survival
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.
Baseline up to data cut-off
Overall survival
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.
Baseline up to data cut-off
Treatment-Related Adverse Events
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.
Baseline up to data cut-off
Exploratory biomarker analysis
Exploratory biomarker to predict treatment response and survival e.g. IHC, DNA-seq, etc.
Baseline up to data cut-off
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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.

Ruijin Hospital logoRuijin Hospital
Study Responsible Party
Zhao Weili, Principal Investigator, Vice president of Ruijin Hospital
Study Central Contact
Contact: Weili Zhao, 086-022-64370045, [email protected]
Contact: Pengpeng Xu, [email protected]
No location data.