Actively Recruiting
SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-01-08
130
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was designed to compare the efficacy and safety of SHR2554 with Chidamide in patients with relapsed/refractory PTCL.
CONDITIONS
Official Title
SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old (inclusive), any gender
- Histologically confirmed T-cell lymphoma
- ECOG physical status of 0 or 1
- Life expectancy of at least 12 weeks
- Relapsed or refractory patients with at least one prior treatment
- No previous treatment with histone deacetylase inhibitors
- Presence of measurable lesions
- Essentially normal bone marrow function
- Essentially normal liver and kidney function
- Essentially normal blood coagulation function
- Female participants of childbearing potential must have a negative pregnancy test before first dose and use effective contraception for 90 days after last dose
- Male participants with partners at risk of pregnancy must be surgically sterilized or use effective contraception for 90 days after last dose
- Recovery from toxic effects of prior treatments before first dosing
- Signed informed consent
- Willingness and ability to comply with study visits, dosing, lab tests, and other procedures
You will not qualify if you...
- Previous treatment with compounds having the same mechanism
- Central nervous system infiltration
- Autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 90 days before consent
- Major surgery or severe trauma within 4 weeks before first dose
- Anti-tumor treatment within 4 weeks or Chinese medicine with anti-tumor effects within 2 weeks before first dose; steroid hormones within 7 days before first dose
- Active hepatitis B or C infection
- History of immunodeficiency including HIV or other acquired/congenital immunodeficiency
- Active infection or unexplained fever above 38.5°C within 2 weeks before initial dosing
- History of severe cardiovascular disease
- Abnormal ECG
- Stroke or transient ischemic attack within 6 months prior to study entry
- Other malignancies within 5 years except certain treated cancers
- Serious acute or chronic illness or mental illness that may increase risks or affect study participation
- Staff or family members related to the research center or sponsor
- Pregnant or lactating women
- Unable to swallow or history of gastrointestinal conditions affecting drug absorption
- Taking known medium or strong CYP inducers
- Any other conditions judged by investigator to prevent study completion or affect results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
M
Min Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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