Clinical trial · Interventional
Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.
Phase II Study of Sintilimab Plus R-CHOP as the First-line Treatment for DLBCL Patients With TP53 Mutation and PD-L1 Positive.
NCT04023916CI-TRIAL-00042175unknownPhase 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 purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Sintilimab | — | UNRESOLVED | — |
| TP53 Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab-R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab-R-CHOP
- description
- Participants with previously untreated DLBCL will receive rituximab and CHOP during Cycle 1 (21-day cycle) and Sintilimab, rituximab, and CHOP during Cycles 2-6 (21-day cycle) ,Sintilimab and rituximab during Cycles 6-8 (21-day cycle) , followed by Sintilimab from Cycles 9-14 (8-week cycle) during consolidation treatment.
- interventionNames
- Drug: Sintilimab-R-CHOP
Primary outcomes (1)
- measure
- complete remission rate
- timeFrame
- every 3 months until 30 months after the last patient's enrollment.
- description
- complete remission rate after treated by Sintilimab+ R-CHOP regimen.
Secondary outcomes (2)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results; 2. Age between 18 to 70 years old; 3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2; 4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment; 5. Life expectancy no less than 6 months; 6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures; 7. Ann Arbor stage I\~ IV 8. previously untreated advanced DLBCL. 9. At least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging) 10. Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of DLBCL. 11. Agree to remain abstinent or use contraceptive measures. Exclusion Criteria: 1. History of autologous stem cell transplantation,radiotherapy or chemotherapy. 2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer; 3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases; 4. Lymphoma originated in the central nervous system; 5. Left ventricular ejection fraction ≦50%; 6. Abnormal lab results in enrollment:Neutrophil count: \<1.5\*10\^9/L;Platelet count \<75\*10\^9/L;AST or ALT \>2 times the upper limit of normal level,AKP and total bilirubin \>1.5 times the upper limit of normal level;serum creatinine \>1.5 times the upper limit of normal level; 7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial; 8. Patients with mental illnesses or other diseases that might not comply with the trial plan; 9. Women during pregnancy or lactation; 10. HIV positive patients; 11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;
References
Publications (0)
Data not yet available
No reference posted for this study.