Can a targeted pill boost Chemo's power against a rare blood cancer?
NCT ID NCT07725705
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial is testing whether adding an experimental targeted drug, SHR2554, to standard chemotherapy (liposomal mitoxantrone) can improve outcomes for people with peripheral T-cell lymphoma (PTCL) who have not yet been treated. The study involves about 44 adults with certain PTCL subtypes. Researchers are looking at safety and how well the combination shrinks tumors, with the possibility of maintenance therapy for those who respond.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an EZH2 inhibitor called SHR2554 combined with liposomal mitoxantrone
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for peripheral T-cell lymphoma, potentially improving response rates and outcomes.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the benefits and risks are not yet well understood. The combination may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
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 to 80 years
- 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. Age ≥18 years old,regardless of gender; 2. Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion. 3. No prior anti-tumor therapy. 4. There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions \>1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma; 5. ECOG performance status score: 0-2; 6. Expected survival time ≥3 months; 7. Have adequate organ and bone marrow functiont; 8. No concurrent hemophagocytic lymphohistiocytosis (HLH). If a patient has clinically diagnosed HLH, enrollment eligibility will be determined by the investigator based on an evaluation of the patient's general physical condition following targeted anti-HLH therapy. 9. Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug. 10. Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).; Exclusion Criteria: 1. Prior treatment with epigenetic agents before enrollment; 2. Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal/pericardial region, cumulative anthracycline dose \> 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) \< 50%, or history of exposure to other cardiotoxic drugs; 3. History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years; 4. Primary central nervous system (CNS) lymphoma or secondary CNS involvement. 5. Known allergy or hypersensitivity to the study drugs or their related metabolites; 6. Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment; 7. Pregnant or lactating women; 8. Active infections; 9. Medical History and Concurrent Conditions; 10. History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS); 11. Patients with mental disorders or those unable to provide informed consent 12. Any other condition deemed by the investigator to be unsuitable for study enrollment;
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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 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.
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