Clinical trial · Interventional
A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment
A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen
NCT06412068CI-TRIAL-00077106unknownPhase 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 multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)
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 |
|---|---|---|---|
| Primary Mediastinal Large B Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined anti-PD-1 and R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients diagnosed with PMBCL.
- interventionNames
- Drug: Combined anti-PD-1 and R-CHOP
Primary outcomes (2)
- measure
- complete remission (CR)
- timeFrame
- 2years
- measure
- overall response rate (ORR)
- timeFrame
- 2 years
- description
- The proportion of patients with a PR and CR
Secondary outcomes (3)
- measure
- overall survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ; * Predicted survival time ≥ 6 months ; * 18-75 years ; * IPI score 0-3; * ECOG performance status 0-2 ; * Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ; * After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ; * WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ; * Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ; * ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ; * Sign the informed consent. Exclusion Criteria: * Other malignant diseases except PMBCL were diagnosed within 5 years;·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma; * Known allergies to test drugs or any excipient component of these products;·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed; * Women in pregnancy or lactation; * Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C; * The researchers believe that there are other potential risks that are not suitable for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.