Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic TherapyPhase 3NCT06122389

SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma

A Phase 3 study testing SHR2554; Chidamide analog tablets and SHR2554 analog tablets; Chidamide in people with Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic Therapy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This study was designed to compare the efficacy and safety of SHR2554 with Chidamide in patients with relapsed/refractory PTCL. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic Therapy
What is being tested?: SHR2554; Chidamide analog tablets and SHR2554 analog tablets; Chidamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteChina
Study dates: 5 Feb 2024to Jul 2026
Phase: Phase 3

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-70 years old (including 18 and 70 years old), gender is not limited;
Histologically confirmed T-cell lymphoma;
ECOG physical status must be 0 or 1;
Life expectancy ≥12 weeks;
For relapsed refractory patients who have received ≥ first-line treatment, at least one prior treatment is adequate;
Have not received histone deacetylase inhibitors;

Show all 14Show fewer

Have measurable lesions;
Bone marrow function is basically normal;
Liver and kidney function is basically normal;
Blood coagulation function is basically normal;
Female subjects with a possibility of becoming pregnant must undergo a blood pregnancy test prior to the first dose, with a negative result, and be willing to use a highly effective method of contraception for 90 days after signing the notification until the last dose of the study drug. Male subjects whose partners are women at risk of becoming pregnant should be surgically sterilized or agree to use highly effective methods of contraception for 90 days from the date of signing the notification until the last administration of the study drug;
The subject has recovered from the toxic effects of the last treatment before the first dosing;
The subject personally signs and dates the informed consent to show that the subject has been fully informed of all the circumstances related to the clinical trial;
Subjects are willing and able to comply with visit schedules, dosing schedules, laboratory examinations, and other clinical trial procedures.

Who cannot join

Have been treated with compounds with the same mechanism;
Accompanied by central nervous system infiltration;
Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation within 90 days;
Major surgery or severe trauma occurred 4 weeks before the first dose of study drug administration;
Received anti-tumor treatment within 4 weeks before the first dose of the study drug, and received Chinese medicine treatment with anti-tumor effect within 2 weeks before the first dose of the study drug; Receiving steroid hormones within 7 days prior to the first dose of study drug administration;
Active phase of HBV or HCV infection;

Show all 18Show fewer

A history of immunodeficiency, including HIV seropositive, or other acquired or congenital immunodeficiency diseases;
Active infection or unexplained fever > 38.5°C within 2 weeks of initial dosing;
A history of clinically severe cardiovascular disease;
Abnormal electrocardiogram (ECG) examination;
Cerebrovascular accident or transient ischemic attack occurred within 6 months before entering the study;
Have other malignancies within 5 years prior to screening, other than adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery (allowing hormone therapy for non-metastatic prostate cancer or breast cancer), and papillary thyroid cancer;
The subject has another serious/severe acute or chronic illness or mental illness, including recent (within the past year) or current suicidal ideation or behavior, or laboratory abnormalities that may increase the risks associated with participation in the study or administration of the investigational drug, may interfere with the interpretation of the study results, or may interfere with the investigator's judgment;
The subjects are the staff of the research center directly related to this clinical trial or their family members, or the subordinates of this trial although not directly related to this trial, or the staff employed by the sponsor directly related to this trial;
Pregnant and lactating women;
The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption;
The subject is taking a known medium or strong CYP inducer;
In the judgment of the investigator, objective conditions (including the subject's psychological state, family relationship, social factors or geographical factors) make the subject unable to complete the planned study or the subject has other factors, concomitant diseases, combined treatment or abnormal laboratory examination that may lead to the forced termination of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Min Li contact

0518-82342973

Min.li.ml150@hengrui.com

China1 site, 1 recruiting

Peking University Cancer Hospital
Beijing, Beijing Municipality, 100000
Yuqin Song, Doctor, 010-88196118, songYQ_vip@163.com
Recruiting

Other trials in China

About this study

Official title: A Double-blinded, Randomized, Multi-center Phase III Clinical Study of SHR2554 Versus Chidamide in Patients With Relapsed/Refractory PTCL

This study was designed to compare the efficacy and safety of SHR2554 with Chidamide in patients with relapsed/refractory PTCL.

Conditions: Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic Therapy
Being tested: SHR2554; Chidamide analog tablets, SHR2554 analog tablets; Chidamide
Medical subject headings: Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR2554; Chidamide analog tabletsDrug
SHR2554 + Chidamide analog tablets
SHR2554 analog tablets; ChidamideDrug
SHR2554 analog tablets + Chidamide

Study groups in NCT06122389
Study group	Role	What they receive
Treatment group A	Experimental	Not described Receives: Drug: SHR2554; Chidamide analog tablets
Treatment group B	Experimental	Not described Receives: Drug: SHR2554 analog tablets; Chidamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS) assessed by IRC
Measured: up to 3 years

Secondary outcomes (1)

Overall Survival (OS)
Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 2024Jul 2026

First posted8 Nov 2023
Study start5 Feb 2024
Primary completionMay 2026 (estimated)
Study completionJul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic TherapyStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: SHR2554 control Chidamide was randomly assigned to either the test group or the control group in a 1:1 ratio
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 130 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06122389
Sponsor's protocol ID: SHR2554-301
Status last verified: Jan 2026
First submitted: 5 Nov 2023
Last updated: 8 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided