Evaluating SHR2554 with Chemotherapy for Peripheral T-cell Lymphoma
A Phase Ib/II, Open-label, Multi-center Study of SHR2554 With CHOP/CHOEP in Treatment-naïve Patients With Peripheral T-cell Lymphoma
This study is testing a new drug called SHR2554 combined with standard chemotherapy to see if it helps people with untreated peripheral T-cell lymphoma feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06173999 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of SHR2554 in combination with standard chemotherapy regimens CHOP and CHOEP in patients who have not previously received treatment for peripheral T-cell lymphoma. It aims to determine how well this new treatment works compared to existing options. Participants will be closely monitored for their response to the treatment and any potential side effects. The study includes both Phase 1 and Phase 2 assessments to gather comprehensive data on the drug's performance.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-70 with histologically confirmed peripheral T-cell lymphoma and an ECOG performance status of 0 or 1.
Not a fit: Patients with active HBV or HCV infections, significant cardiovascular disease, or those who have had other malignancies within the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with peripheral T-cell lymphoma.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating peripheral T-cell lymphoma with novel agents combined with chemotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yang Wu
- Email: yang.wu.yw96@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.