Peripheral T-cell LymphomaPhase 1/2NCT06173999
A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma
A Phase 1/2 study testing SHR2554/CHOP and SHR2554/CHOEP in people with Peripheral T-cell Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- SHR2554/CHOP and SHR2554/CHOEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18-70 years (inclusive);
- Histologically confirmed peripheral T-cell lymphoma;
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Have measurable lesions ;
- The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.
Who cannot join
- Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
- Known active HBV or HCV infection;
- History of clinically significant cardiovascular disease;
- History of other malignancies within 5 years;
- Pregnant or lactating women;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Doctor, 010-88196118, songyuqin622@163.com
About this study
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
The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- SHR2554/CHOP, SHR2554/CHOEP
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554/CHOPDrug
SHR2554 with CHOP
SHR2554/CHOEPDrug
SHR2554 with CHOEP
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR2554/CHOP |
| Treatment group B | Experimental | Not described Receives: Drug: SHR2554/CHOEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints: incidence and severity of adverse events (AEs)
Ib phase
Measured: through study completion, an average of about 6 months
Overall response rate (ORR)
II phase
Measured: 90 days since the date of first dose
Secondary outcomes (5)
Plasma concentration
Ib phase
Measured: Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle)
Progression Free Survival (PFS)
II phase
Measured: through study completion, an average of about 6 months
Overall Survival (OS)
II phase
Measured: 2 years since the date of first dose
Duration of response (DOR)
II phase
Measured: through study completion, an average of about 6 months
Incidence and severity of adverse events (AEs)
II phase
Measured: through study completion, an average of about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start22 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- SHR2554 with CHOP/CHOEP.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173999
- Sponsor's protocol ID
- SHR2554-201
- Status last verified
- May 2024
- First submitted
- 8 Dec 2023
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06173999
- Acronym / sponsor ID
- SHR2554-201
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SHR2554 with CHOP/CHOEP.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR2554/CHOP |
| Treatment group B | Experimental | Drug: SHR2554/CHOEP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females aged 18-70 years (inclusive);
- Histologically confirmed peripheral T-cell lymphoma;
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Have measurable lesions ;
Key exclusion criteria (6 listed)
- Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
- Known active HBV or HCV infection;
- History of clinically significant cardiovascular disease;
- History of other malignancies within 5 years;
- Pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR2554/CHOPSHR2554 with CHOP | Drug | Treatment group A |
| SHR2554/CHOEPSHR2554 with CHOEP | Drug | Treatment group B |
Primary outcome
Safety endpoints: incidence and severity of adverse events (AEs)
Time frame: through study completion, an average of about 6 months
Ib phase
Overall response rate (ORR)
Time frame: 90 days since the date of first dose
II phase
5 secondary outcomes
Plasma concentration
Time frame: 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
Overall Survival (OS)
Time frame: 2 years since the date of first dose
Duration of response (DOR)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR2554/CHOP and SHR2554/CHOEP in people with Peripheral T-cell Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Wu (0518-82342973, yang.wu.yw96@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoints: incidence and severity of adverse events (AEs) (time frame: through study completion, an average of about 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.