New pill aims to extend remission in rare blood cancer
NCT ID NCT07347288
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called SHR2554 as a maintenance therapy for people with peripheral T-cell lymphoma who have responded to initial treatment. The goal is to see if taking this pill can help keep the cancer from progressing for longer. About 30 adults who have achieved complete or partial remission after first-line therapy will take SHR2554 and be monitored for side effects and disease control.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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. Age ≥18 years old 2. Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria. 3. Previously received first-line systemic induction therapy and achieved CR/PR; Auto-transplantation or allo-transplantation are allowed. 4. A measurable or evaluable disease at the time of first diagnosis of PTCL (any nodes/nodal masses\>1.5 cm in longest diameter (LDi) or extralymphatic sites of disease \>1.0 cm in LDi) 5. ECOG PS 0-2 6. With adequate organ function 7. Expected survival ≥ 12 weeks 8. Women of childbearing potential (WOCBP) should be proven to be negative by human chorionic gonadotropin (hCG) test in 7 days before the first dose of SHR2554. They must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from the day they sign the informed consent form (ICF) to at least 30 days after receiving the last dose of study treatment. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy; 9. Participant who has provided written consent to participate in the study and ability to comply with all aspects of the protocol. Exclusion Criteria: 1. cutaneous T cell lymphoma 2. Has a prior malignancy other than the malignancies under study within 3 years without relieve 3. Participants with a presence of central nerves invasion 4. Known sensitivity or allergy to investigational product 5. Participated in another clinical trial within 4 weeks prior to the start of the study; 6. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures 7. Active infected persons, except tumor-related B symptom fever; 8. Diseases and medical history: 1.have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 2.have a history of psychotropic substance abuse and can not quit or have mental disorders; 3.Subjects with any severe and/or uncontrolled medical condition; 9.A history of immunodeficiency 10.Patients with mental disorders or those unable to provide informed consent 11.In any conditions which investigator considered ineligible for this study.
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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 with Nanjing Medical University
Nanjing, Jiangsu, 210000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New study aims to decode PTCL by genetic subtype
- New hope for tough lymphoma: TR115 faces off against standard care
- New CAR-T therapy targets tough T-Cell cancers in early trial
- New drug cocktail takes on hard-to-treat lymphomas