Peripheral T Cells Lymphoma (PTCL)Phase 2NCT07372352
Zeprumetostat, Azacitidine Combined With Lipo-MIT in R/R PTCL
A Phase 2 study testing Zeprumetostat, Azacitidine (AZA) and Mitoxantrone Hydrochloride Liposome in people with Peripheral T Cells Lymphoma (PTCL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This clinical trial is a Phase II study investigating the effectiveness and safety of a three-drug combination-Zeprumetostat, Azacitidine, and Mitoxantrone Hydrochloride Liposome-in adults with relapsed or 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
- Peripheral T Cells Lymphoma (PTCL)
- What is being tested?
- Zeprumetostat, Azacitidine (AZA) and Mitoxantrone Hydrochloride Liposome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 15 Jul 2029
- Phase
- Phase 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
- Relapsed or refractory peripheral T-cell lymphoma after first-line or higher treatment.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- Presence of measurable target lesions [Note: Target lesions are defined as lesions with at least one longest diameter (LD) measurement > 1.5 cm and longest perpendicular diameter (LPD) measurement ≥ 1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI). A maximum of six target lesions can be selected].
- Adequate function of major organs must meet the following criteria:
- Hematological parameters: HB ≥ 70 g/L, PLT ≥ 50 × 10^9/L, NE ≥ 1.0 × 10^9/L (Note: Patients who have not received transfusions or drugs to support NE, PLT, or HB increase within 1 week before screening are eligible. Patients with bone marrow involvement by lymphoma resulting in cytopenia are not restricted by this criterion).
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- Echocardiographic left ventricular ejection fraction ≥ 50%.
- Creatinine ≤ 132 umol/L or creatinine clearance ≥ 60 ml/min.
- ALT and AST ≤ 3 times the upper limit of normal.
- Women of childbearing potential must have a negative pregnancy test. Both male and female patients must agree to use effective contraception during treatment and for 1 year thereafter.
- Life expectancy of more than 3 months.
- Voluntary signed informed consent form.
Who cannot join
- Underwent major surgery or severe trauma within 2 weeks before enrollment, or significant adverse effects have not yet recovered.
- Currently suffering from or having had other malignancies within 3 years before enrollment, except for cured basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ.
- History of stroke or intracranial hemorrhage within the past 3 months.
- Presence of complications or medical conditions that may interfere with the conduct of the study or pose a significant risk to the patient, including but not limited to severe cardiovascular diseases (e.g., cardiac disease classified as New York Heart Association class III or IV, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina) and/or severe pulmonary diseases (e.g., severe obstructive pulmonary disease and history of symptomatic bronchospasm).
- Human immunodeficiency virus infection, or presence of uncontrollable active hepatitis C virus or hepatitis B virus infection.
- Uncontrollable active infection.
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- Pregnant or breastfeeding women.
- Any life-threatening disease, medical condition, or organ system dysfunction that may endanger the safety of the patient, as determined by the investigator.
- Any condition that may interfere with the absorption or metabolism of zemtovistat, azacitidine, or doneda, or place the study results at unnecessary risk.
- Lymphoma involvement of the central nervous system.
- Presence of conditions judged by the investigator to interfere with full participation in the study; conditions posing significant risk to the subject; or conditions that may interfere with the interpretation of study data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Ting Xu, DOCTOR, +86-512-67781831, LI_jiaqi7777@163.com
About this study
Official title: Clinical Study on the Efficacy and Safety of Zeprumetostat, Azacitidine Combined With Mitoxantrone Hydrochloride Liposome in Relapsed/Refractory Peripheral T-Cell Lymphoma.
This clinical trial is a Phase II study investigating the effectiveness and safety of a three-drug combination-Zeprumetostat, Azacitidine, and Mitoxantrone Hydrochloride Liposome-in adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL is an aggressive type of non-Hodgkin lymphoma that has limited treatment options after the first line of therapy.
The study aims to enroll approximately 26 patients at a single center in China. Eligible participants will receive up to 6 cycles of induction therapy with all three drugs, followed by up to 2 years of maintenance therapy with Zeprumetostat alone if they respond to treatment.
Read more
The main goal is to evaluate the overall response rate (how many patients experience tumor shrinkage). Secondary goals include assessing how long patients live without their disease getting worse, how long they survive overall, and the safety profile of this treatment combination. The study will also explore whether specific genetic markers or viral infections are linked to how well patients respond.
This study is important because it tests a novel, potentially less toxic, and more effective combination for a patient population with high unmet medical need. All participants will be closely monitored for treatment response and side effects throughout the trial.
- Conditions
- Peripheral T Cells Lymphoma (PTCL)
- Being tested
- Zeprumetostat, Azacitidine (AZA), Mitoxantrone Hydrochloride Liposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZeprumetostatDrug
Zeprumetostat is an oral, selective Enhancer of Zeste Homolog 2 (EZH2) inhibitor. EZH2 is a histone methyltransferase often dysregulated in lymphomas. By inhibiting EZH2, zeprumetostat modulates epigenetic programming to reverse aberrant gene silencing, induce cell cycle arrest and apoptosis. In this study, it is administered at 350 mg orally twice daily continuously. It is used both in the 6-cycle induction combination phase and as monotherapy in the up to 2-year maintenance phase for responding patients.
Azacitidine (AZA)Drug
Azacitidine is a DNA methyltransferase inhibitor (hypomethylating agent). As a cytidine analog, it incorporates into DNA and RNA, leading to DNA hypomethylation, reactivation of silenced tumor suppressor genes, and direct cytotoxicity. In this study, azacitidine is administered at 100 mg via subcutaneous injection once daily on Days 1-5 of each 21-day induction cycle. It is part of the initial triple-drug induction regimen and is not used during the subsequent maintenance phase.
Mitoxantrone Hydrochloride LiposomeDrug
Mitoxantrone Hydrochloride Liposome is a liposomal formulation of the anthracenedione chemotherapy agent mitoxantrone. The liposomal encapsulation aims to improve pharmacokinetics and tissue distribution. Its mechanism involves intercalating into DNA and inhibiting topoisomerase II, causing DNA strand breaks and cell death. In this study, it is administered intravenously at 16 mg/m² on Day 1 of each 21-day induction cycle. It is used only in the initial 6-cycle combination induction phase.
| Study group | Role | What they receive |
|---|---|---|
| Zeprumetostat + Azacitidine + Lipo-MIT. | Experimental | This single-arm, Phase II study evaluates a combination regimen followed by monotherapy maintenance. All participants receive up to six 21-day cycles of induction therapy: Zeprumetostat (350 mg orally twice daily continuously), Azacitidine (100 mg subcutaneous injection on days 1-5), and Mitoxantrone Hydrochloride Liposome(Lipo-MIT) (16 mg/m² IV on day 1). Response is formally assessed after Cycle 3. Only patients achieving a Complete Response (CR) or Partial Response (PR) proceed to complete Cycles 4-6. Patients with CR or PR after induction then enter a maintenance phase of up to 2 years with Zeprumetostat monotherapy (350 mg orally twice daily). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the maintenance period. Protocol-defined dose modifications are permitted for adverse events. Receives: Drug: Zeprumetostat; Drug: Azacitidine (AZA); Drug: Mitoxantrone Hydrochloride Liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) after 6 treatment cycles
The proportion of participants who achieve a Complete Response (CR) or Partial Response (PR) per the Lugano 2014 classification.
Measured: Efficacy will be assessed at the end of the induction therapy (6 cycles in total). Each treatment cycle is 21 days.
Secondary outcomes (5)
Progression-Free Survival (PFS)
Measured: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Complete Response (CR) Rate after 6 treatment cycles
Measured: Efficacy will be assessed at the end of induction therapy (6 cycles in total). Each treatment cycle is 21 days.
Duration of Response (DOR)
Measured: From the date of first documented response (partial or complete) until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Overall Survival (OS)
Measured: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Incidence of Treatment-Emergent Adverse Events (Safety)
Measured: From the first dose of study treatment until 30 days after the last dose, or until the start of new anti-cancer therapy, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cells Lymphoma (PTCL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372352
- Sponsor's protocol ID
- 20251196
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Zeprumetostat, Azacitidine Combined With Mitoxantrone Hydrochloride Liposome in Relapsed/Refractory Peripheral T-Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT07372352
- Acronym / sponsor ID
- 20251196
- Conditions
- Peripheral T Cells Lymphoma (PTCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 28 Jan 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.
This clinical trial is a Phase II study investigating the effectiveness and safety of a three-drug combination-Zeprumetostat, Azacitidine, and Mitoxantrone Hydrochloride Liposome-in adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL is an aggressive type of non-Hodgkin lymphoma that has limited treatment options after the first line of therapy.
The study aims to enroll approximately 26 patients at a single center in China. Eligible participants will receive up to 6 cycles of induction therapy with all three drugs, followed by up to 2 years of maintenance therapy with Zeprumetostat alone if they respond to treatment.
The main goal is to evaluate the overall response rate (how many patients experience tumor shrinkage). Secondary goals include assessing how long patients live without their disease getting worse, how long they survive overall, and the safety profile of this treatment combination. The study will also explore whether specific genetic markers or viral infections are linked to how well patients respond.
This study is important because it tests a novel, potentially less toxic, and more effective combination for a patient population with high unmet medical need. All participants will be closely monitored for treatment response and side effects throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zeprumetostat + Azacitidine + Lipo-MIT. | Experimental | Drug: Zeprumetostat, Drug: Azacitidine (AZA), Drug: Mitoxantrone Hydrochloride LiposomeThis single-arm, Phase II study evaluates a combination regimen followed by monotherapy maintenance. All participants receive up to six 21-day cycles of induction therapy: Zeprumetostat (350 mg orally twice daily continuously), Azacitidine (100 mg subcutaneous injection on days 1-5), and Mitoxantrone Hydrochloride Liposome(Lipo-MIT) (16 mg/m² IV on day 1). Response is formally assessed after Cycle 3. Only patients achieving a Complete Response (CR) or Partial Response (PR) proceed to complete Cycles 4-6. Patients with CR or PR after induction then enter a maintenance phase of up to 2 years with Zeprumetostat monotherapy (350 mg orally twice daily). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the maintenance period. Protocol-defined dose modifications are permitted for adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Relapsed or refractory peripheral T-cell lymphoma after first-line or higher treatment.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- Presence of measurable target lesions [Note: Target lesions are defined as lesions with at least one longest diameter (LD) measurement > 1.5 cm and longest perpendicular diameter (LPD) measurement ≥ 1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI). A maximum of six target lesions can be selected].
- Adequate function of major organs must meet the following criteria:
Key exclusion criteria (11 listed)
- Underwent major surgery or severe trauma within 2 weeks before enrollment, or significant adverse effects have not yet recovered.
- Currently suffering from or having had other malignancies within 3 years before enrollment, except for cured basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ.
- History of stroke or intracranial hemorrhage within the past 3 months.
- Presence of complications or medical conditions that may interfere with the conduct of the study or pose a significant risk to the patient, including but not limited to severe cardiovascular diseases (e.g., cardiac disease classified as New York Heart Association class III or IV, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina) and/or severe pulmonary diseases (e.g., severe obstructive pulmonary disease and history of symptomatic bronchospasm).
- Human immunodeficiency virus infection, or presence of uncontrollable active hepatitis C virus or hepatitis B virus 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 |
|---|---|---|
| ZeprumetostatZeprumetostat is an oral, selective Enhancer of Zeste Homolog 2 (EZH2) inhibitor. EZH2 is a histone methyltransferase often dysregulated in lymphomas. By inhibiting EZH2, zeprumetostat modulates epigenetic programming to reverse aberrant gene silencing, induce cell cycle arrest and apoptosis. In this study, it is administered at 350 mg orally twice daily continuously. It is used both in the 6-cycle induction combination phase and as monotherapy in the up to 2-year maintenance phase for responding patients. | Drug | Zeprumetostat + Azacitidine + Lipo-MIT. |
| Azacitidine (AZA)Azacitidine is a DNA methyltransferase inhibitor (hypomethylating agent). As a cytidine analog, it incorporates into DNA and RNA, leading to DNA hypomethylation, reactivation of silenced tumor suppressor genes, and direct cytotoxicity. In this study, azacitidine is administered at 100 mg via subcutaneous injection once daily on Days 1-5 of each 21-day induction cycle. It is part of the initial triple-drug induction regimen and is not used during the subsequent maintenance phase. | Drug | Zeprumetostat + Azacitidine + Lipo-MIT. |
| Mitoxantrone Hydrochloride LiposomeMitoxantrone Hydrochloride Liposome is a liposomal formulation of the anthracenedione chemotherapy agent mitoxantrone. The liposomal encapsulation aims to improve pharmacokinetics and tissue distribution. Its mechanism involves intercalating into DNA and inhibiting topoisomerase II, causing DNA strand breaks and cell death. In this study, it is administered intravenously at 16 mg/m² on Day 1 of each 21-day induction cycle. It is used only in the initial 6-cycle combination induction phase. | Drug | Zeprumetostat + Azacitidine + Lipo-MIT. |
Primary outcome
Objective Response Rate (ORR) after 6 treatment cycles
Time frame: Efficacy will be assessed at the end of the induction therapy (6 cycles in total). Each treatment cycle is 21 days.
The proportion of participants who achieve a Complete Response (CR) or Partial Response (PR) per the Lugano 2014 classification.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Complete Response (CR) Rate after 6 treatment cycles
Time frame: Efficacy will be assessed at the end of induction therapy (6 cycles in total). Each treatment cycle is 21 days.
Duration of Response (DOR)
Time frame: From the date of first documented response (partial or complete) until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Overall Survival (OS)
Time frame: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Incidence of Treatment-Emergent Adverse Events (Safety)
Time frame: From the first dose of study treatment until 30 days after the last dose, or until the start of new anti-cancer therapy, whichever occurs first.
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 28 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zeprumetostat, Azacitidine (AZA) and Mitoxantrone Hydrochloride Liposome in people with Peripheral T Cells Lymphoma (PTCL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 12 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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 Ting Xu, Doctor (+86-512-67781831, 21132075@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) after 6 treatment cycles (time frame: Efficacy will be assessed at the end of the induction therapy (6 cycles in total). Each treatment cycle is 21 days.). 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 28 Jan 2026.