PTCLPhase 1/2NCT07493330
Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL
A Phase 1/2 study testing Zeprumetostat+Azacitadine, Zeprumetostat+Decitabine and Zeprumetostat+Chidamide in people with PTCL and Refractory, run by Ruijin Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTCL, Refractory
- What is being tested?
- Zeprumetostat+Azacitadine, Zeprumetostat+Decitabine and Zeprumetostat+Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2026to 12 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate organ function
- Contraception during study
- Informed consented
Who cannot join
- 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:
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Pengpeng Xu contact
About this study
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
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).
Read the 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 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.
- Conditions
- PTCL, Refractory
- Being tested
- Zeprumetostat+Azacitadine, Zeprumetostat+Decitabine, Zeprumetostat+Chidamide, Zeprumetostat+Golidocitinib
- Keywords
- PTCL, Genotype-guided, Zeprumetostat, Refractory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeprumetostat+AzacitadineDrug
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+DecitabineDrug
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+ChidamideDrug
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+GolidocitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Zeprumetostat+Azacitadine (if with TET2 plus RHOA gene mutation) | Experimental | 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. Receives: Drug: Zeprumetostat+Azacitadine |
| Zeprumetostat+Decitabine (if with TP53 gene mutation) | Experimental | 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. Receives: Drug: Zeprumetostat+Chidamide |
| Zeprumetostat+Chidamide (if with CREBBP/EP300/KMT2C/KMT2D/NCOR2 gene mutation) | Experimental | 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. Receives: Drug: Zeprumetostat+Decitabine |
| Zeprumetostat+Golidocitinib (if not above genotype) | Experimental | 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. Receives: Drug: Zeprumetostat+Golidocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of DLT events (Phase Ib)
Measure Description: Enroll 6 pts per cohort and observe the number of pts experiencing dose-limiting toxicity.
Measured: 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
Measured: At the end of Cycle 3 (each cycle is 28 days)
Secondary outcomes (8)
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to data cut-off
Exploratory biomarker analysis
Exploratory biomarker to predict treatment response and survival
Measured: Baseline up to data cut-off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion12 Dec 2029 (estimated)
- Study completion12 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493330
- Sponsor's protocol ID
- Target
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07493330
- Acronym / sponsor ID
- Target
- Conditions
- PTCL, Refractory
- Keywords
- PTCL, Genotype-guided, Zeprumetostat, Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 12 Dec 2029 (estimated)
- Study completion
- 12 Dec 2030 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zeprumetostat+Azacitadine (if with TET2 plus RHOA gene mutation) | Experimental | Drug: Zeprumetostat+AzacitadineZeprumetostat: 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 (if with TP53 gene mutation) | Experimental | Drug: Zeprumetostat+ChidamideZeprumetostat: 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 (if with CREBBP/EP300/KMT2C/KMT2D/NCOR2 gene mutation) | Experimental | Drug: Zeprumetostat+DecitabineZeprumetostat: 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 (if not above genotype) | Experimental | Drug: Zeprumetostat+GolidocitinibZeprumetostat: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zeprumetostat+AzacitadineZeprumetostat: 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. | Drug | Zeprumetostat+Azacitadine (if with TET2 plus RHOA gene mutation) |
| Zeprumetostat+DecitabineZeprumetostat: 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. | Drug | Zeprumetostat+Chidamide (if with CREBBP/EP300/KMT2C/KMT2D/NCOR2 gene mutation) |
| Zeprumetostat+ChidamideZeprumetostat: 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. | Drug | Zeprumetostat+Decitabine (if with TP53 gene mutation) |
| Zeprumetostat+GolidocitinibZeprumetostat: 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. | Drug | Zeprumetostat+Golidocitinib (if not above genotype) |
Primary outcome
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.
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
8 secondary outcomes
Complete response rate
Time frame: At the end of Cycle 3
Disease Control Rate
Time frame: each cycle is 28 days
Duration of response
Time frame: Baseline up to data cut-off
Duration of complete response
Time frame: Baseline up to data cut-off
Progression free survival
Time frame: Baseline up to data cut-off
Overall survival
Time frame: Baseline up to data cut-off
Treatment-Related Adverse Events
Time frame: Baseline up to data cut-off
Exploratory biomarker analysis
Time frame: Baseline up to data cut-off
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pengpeng Xu contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zeprumetostat+Azacitadine, Zeprumetostat+Decitabine and Zeprumetostat+Chidamide in people with PTCL and Refractory, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (086-022-64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of DLT events (Phase Ib) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.