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

December 8, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A
Drug: SHR2554/CHOP
SHR2554 with CHOP
Experimental: Treatment group B
Drug: SHR2554/CHOEP
SHR2554 with CHOEP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR2554-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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