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

Last updated: May 11, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Non-hodgkin's Lymphoma

T-cell Lymphoma

Treatment

SHR2554/CHOP

SHR2554/CHOEP

Clinical Study ID

NCT06173999
SHR2554-201
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Underwent major surgery or experienced severe trauma within 4 weeks prior to thefirst 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 mayprevent the subject from completing the study as planned or the subject has otherfactors, concomitant diseases, concomitant treatments, or abnormal laboratoryfindings that may lead to early study termination.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: SHR2554/CHOP
Phase: 1/2
Study Start date:
December 22, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

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