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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-22

Study Completion Date

2025-12-31

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.

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Detailed Description

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Conditions

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Peripheral T-cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

SHR2554 with CHOP/CHOEP.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group A

Group Type EXPERIMENTAL

SHR2554/CHOP

Intervention Type DRUG

SHR2554 with CHOP

Treatment group B

Group Type EXPERIMENTAL

SHR2554/CHOEP

Intervention Type DRUG

SHR2554 with CHOEP

Interventions

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SHR2554/CHOP

SHR2554 with CHOP

Intervention Type DRUG

SHR2554/CHOEP

SHR2554 with CHOEP

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No