Clinical trial · Interventional
Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL
NCT04835870CI-TRIAL-00060889unknownPhase 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)
Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients
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 |
|---|---|---|---|
| Non-GCB/ABC Diffuse Large B-Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOP + Zanubrutinib
- description
- Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
- interventionNames
- Drug: Zanubrutinib
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
Primary outcomes (1)
- measure
- Progression-free Survival(PFS)
- timeFrame
- up to 18 months
- description
- To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
Secondary outcomes (5)
- measure
- Overall Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed Non-GCB DLBCL with extrinsic involvement 2. Age ≥ 18 years 3. Measurable disease of at least 15mm(node)/10mm(extranodal) 4. ECOG performance status 0-2 5. Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN 6. Adequate bone marrow function:Platelet count (≥ 50×10\^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10\^9/L) 7. Estimated survival time ≥3 months 8. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study Exclusion Criteria: 1. Accepted major surgery within 4 weeks before treatment; 2. Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma; 3. Previous history of indolent lymphoma; 4. Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ; 5. History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists; 6. Requires treatment with a strong/medium CYP3A inducer; 7. The previous use of anthracycline-based drugs \> 150 mg/m2; 8. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease; 9. HIV infection and/or active hepatitis B or active hepatitis C; 10. Uncontrolled systemic infection; 11. Pregnant or breasting-feeding women; 12. According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.
References
Publications (1)
- DERIVEDGeng H, Jia S, Zhang Y, Li J, Yang Q, Zeng L, Zong X, Lu Y, Lu S, Zhou J, Li C, Wu D. Efficacy and safety of zanubrutinib plus R-CHOP in treatment of non-GCB DLBCL with extranodal involvement. Front Immunol. 2023 Aug 21;14:1219167. doi: 10.3389/fimmu.2023.1219167. eCollection 2023. PMID 37671152