Clinical trial · Interventional
A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With 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
NCT06173999CI-TRIAL-00077118unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR2554/CHOEP | Drug | — | UNRESOLVED |
| SHR2554/CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group A
- interventionNames
- Drug: SHR2554/CHOP
- type
- EXPERIMENTAL
- label
- Treatment group B
- interventionNames
- Drug: SHR2554/CHOEP
Primary outcomes (2)
- measure
- Safety endpoints: incidence and severity of adverse events (AEs)
- timeFrame
- through study completion, an average of about 6 months
- description
- Ib phase
- measure
- Overall response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.