A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma

Study Overview
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Brief Summary
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The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.

Official Title
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A Phase Ib/II, Open-label, Multi-center Study of SHR2554 With CHOP/CHOEP in Treatment-naïve Patients With Peripheral T-cell Lymphoma

Conditions
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Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: SHR2554/CHOP
* Drug: SHR2554/CHOEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: SHR2554 with CHOP/CHOEP.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: SHR2554/CHOP<br>* SHR2554 with CHOP<br>|
| Experimental: Treatment group B<br> | Drug: SHR2554/CHOEP<br>* SHR2554 with CHOEP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints: incidence and severity of adverse events (AEs) | Ib phase | through study completion, an average of about 6 months | 
| Overall response rate (ORR) | II phase | 90 days since the date of first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration | Ib phase | Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle) | 
| Progression Free Survival (PFS) | II phase | through study completion, an average of about 6 months | 
| Overall Survival (OS) | II phase | 2 years since the date of first dose | 
| Duration of response (DOR) | II phase | through study completion, an average of about 6 months | 
| Incidence and severity of adverse events (AEs) | II phase | through study completion, an average of about 6 months |