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

Peripheral T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173999
• Other study ID #: SHR2554-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 22, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yang Wu
• Phone: 0518-82342973
• Email: yang.wu.yw96[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• SHR2554/CHOP
SHR2554 with CHOP
• SHR2554/CHOEP
SHR2554 with CHOEP

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoints: incidence and severity of adverse events (AEs)	Ib phase	through study completion, an average of about 6 months
Primary	Overall response rate (ORR)	II phase	90 days since the date of first dose
Secondary	Plasma concentration	Ib phase	Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle)
Secondary	Progression Free Survival (PFS)	II phase	through study completion, an average of about 6 months
Secondary	Overall Survival (OS)	II phase	2 years since the date of first dose
Secondary	Duration of response (DOR)	II phase	through study completion, an average of about 6 months
Secondary	Incidence and severity of adverse events (AEs)	II phase	through study completion, an average of about 6 months