Clinical trial
A Phase Ib/II, Open-label, Multi-center Study of SHR2554 With CHOP/CHOEP in Treatment-naïve Patients With Peripheral T-cell Lymphoma
Name
SHR2554-201
Description
The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
Trial arms
Trial start
2023-12-31
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
SHR2554/CHOP
SHR2554 with CHOP
Arms:
Treatment group A
SHR2554/CHOEP
SHR2554 with CHOEP
Arms:
Treatment group B
Size
100
Primary endpoint
Safety endpoints: incidence and severity of adverse events (AEs)
through study completion, an average of about 6 months
Overall response rate (ORR)
90 days since the date of first dose
Eligibility criteria
Inclusion Criteria:
1. Males or females aged 18-70 years (inclusive);
2. Histologically confirmed peripheral T-cell lymphoma;
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
4. Life expectancy ≥ 12 weeks;
5. Have measurable lesions ;
6. The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.
Exclusion Criteria:
1. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
2. Known active HBV or HCV infection;
3. History of clinically significant cardiovascular disease;
4. History of other malignancies within 5 years;
5. Pregnant or lactating women;
6. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'SHR2554 with CHOP/CHOEP.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-12-18
1 organization
2 products
1 indication
Organization
Jiangsu HengRui MedicineProduct
SHR2554/CHOPIndication
Peripheral T-cell LymphomaProduct
SHR2554/CHOEP