Peripheral T-cell Lymphoma
Conditions
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.
Interventions
DRUGSHR2554/CHOP
SHR2554 with CHOP
DRUGSHR2554/CHOEP
SHR2554 with CHOEP
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR2554 with CHOP/CHOEP.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints: incidence and severity of adverse events (AEs) | through study completion, an average of about 6 months | Ib phase |
| Overall response rate (ORR) | 90 days since the date of first dose | II phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 2 years since the date of first dose | II phase |
| Plasma concentration | Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle) | Ib phase |
| Incidence and severity of adverse events (AEs) | through study completion, an average of about 6 months | II phase |
| Duration of response (DOR) | through study completion, an average of about 6 months | II phase |
| Progression Free Survival (PFS) | through study completion, an average of about 6 months | II phase |
Countries
China
Contacts
Primary ContactYang Wu
Outcome results
None listed