Promising new combo offers hope for aggressive lymphoma that stopped responding to treatment
NCT ID NCT07372352
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (zeprumetostat, azacitidine, and mitoxantrone hydrochloride liposome) in about 26 adults with peripheral T-cell lymphoma that has come back or not responded to prior treatment. The goal is to see if this mix can shrink tumors and help people live longer without the cancer growing. Participants will receive up to 6 cycles of the combo, then up to 2 years of a single maintenance drug if they respond. The trial closely tracks both benefits and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Relapsed or refractory peripheral T-cell lymphoma after first-line or higher treatment. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2. 4. Presence of measurable target lesions \[Note: Target lesions are defined as lesions with at least one longest diameter (LD) measurement \> 1.5 cm and longest perpendicular diameter (LPD) measurement ≥ 1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI). A maximum of six target lesions can be selected\]. 5. 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). * 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. 6. 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. 7. Life expectancy of more than 3 months. 8. Voluntary signed informed consent form. Exclusion Criteria: 1. Underwent major surgery or severe trauma within 2 weeks before enrollment, or significant adverse effects have not yet recovered. 2. 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. 3. History of stroke or intracranial hemorrhage within the past 3 months. 4. 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). 5. Human immunodeficiency virus infection, or presence of uncontrollable active hepatitis C virus or hepatitis B virus infection. 6. Uncontrollable active infection. 7. Pregnant or breastfeeding women. 8. Any life-threatening disease, medical condition, or organ system dysfunction that may endanger the safety of the patient, as determined by the investigator. 9. Any condition that may interfere with the absorption or metabolism of zemtovistat, azacitidine, or doneda, or place the study results at unnecessary risk. 10. Lymphoma involvement of the central nervous system. 11. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215000, China
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