Status:
RECRUITING
A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
Eligibility Criteria
Inclusion
- Males or females aged 18-70 years (inclusive);
- Histologically confirmed peripheral T-cell lymphoma;
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Have measurable lesions ;
- The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.
Exclusion
- Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
- Known active HBV or HCV infection;
- History of clinically significant cardiovascular disease;
- History of other malignancies within 5 years;
- Pregnant or lactating women;
- Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination.
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06173999
Start Date
December 22 2023
End Date
December 31 2025
Last Update
May 14 2024
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142