Diffuse large B-cell lymphoma (DLBCL)
Conditions
Interventions
Experimental group:RCHOP combined with Zanubrutinib
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. Have not received systemic therapy for DLBCL before; 3. Histologically confirmed non-GCB DLBCL; 4. There are PET/CT evaluation results before RCHOP treatment, and it is confirmed as having PET-affinity disease; 5. Measurable lesions are defined as at least one lymph node lesion with the longest diameter > 1.5 cm, or at least one extranodal lesion > 1.0 cm in the longest diameter, and at least two vertical diameters that can be accurately measured; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 7. Clinical stage II (not suitable for local radiotherapy), III, IV (Ann Arbor stage); 8. After IPI>=12 cycles of RCHOP treatment; 9. Positive PET after 2 cycles of R-CHOP treatment (Deauville score 4 or 5); 10. Adequate hematological function, defined as: (1) Absolute neutrophil count (ANC) >=1x10^9/L within 7 days before entering the study; (2) Platelet count >= 75 x 10^9/L within 7 days before entering the study (if there is bone marrow involvement, platelet count >= 50 x 10^9/L). 11. International normalized ratio (INR)=40 ml/min (assessed according to Cockcroft-Gault formula or estimated glomerular filtration rate [eGFR] from Diet Modification for Renal Disease [MDRD] formula); 13. Adequate liver function, defined as: (1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 months; 17. Be able to sign the informed consent in writing, and be able to understand and abide by the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Major surgery within 4 weeks before RCHOP treatment; 2. Received BTK inhibitor treatment, the cumulative use of anthracyclines in the past is >=150 mg/m2; 3. Suffering from central nervous system (CNS) lymphoma or mediastinal large B-cell lymphoma; 4. Histologically transformed large cell lymphoma; 5. There is a history of other active malignant diseases within 2 years before entering the study, with the following exceptions: (1) adequately treated in situ cervical cancer; (2) Local skin basal cell carcinoma or squamous cell carcinoma; (3) Past malignant disease that has been controlled and has undergone local radical treatment (surgery or other forms). 6. History of severe bleeding disorders, such as hemophilia A, hemophilia B, von Willebrand's disease, or history of spontaneous bleeding that requires blood transfusion or other medical intervention; 7. There is any life-threatening disease, medical condition or organ system insufficiency that the investigator believes may affect the safety of the subject or cause research risks; 8. Known human immunodeficiency virus (HIV) infection; 9. Pregnant or lactating women; 10. Patients with disease progression assessed by PET/CT and or enhanced CT after two cycles of RCHOP; 11. History of stroke or intracranial hemorrhage within 6 months before the first study drug administration; 12. Suffering from clinically significant cardiovascular disease, including: (1) Myocardial infarction occurred within 6 months before screening; (2) Unstable angina pectoris occurred within 3 months before screening; (3) Clinically significant arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); (4) QTcF (corrected by Fridericia formula) > 480 mse or other ECG abnormalities, including a history of second-degree type II atrioventricular (AV) block or third-degree AV block; (5) Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional classification; (6) Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) less than 50% (AHA, 2016); (7) Uncontrolled hypertension at screening, manifested as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg in at least two consecutive blood pressure measurements. 13. Active fungal, bacterial and/or viral infections requiring systemic treatment; 14. Can not swallow capsules or have diseases that significantly affect the function of the gastrointestinal tract, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction; 15. Requires continued treatment with potent and moderate CYP3A inhibitors or CYP3A inducers. Patients are not eligible if they have taken a strong or moderate CYP3A inhibitor or inducer within 7 days prior to the first dose of study drug (or have taken these drugs for less than 5 half-lives); 16. Pregnant or lactating women; 17. Hypersensitivity to zanubrutinib or any other component of the study drug; 18. Participate in another clinical trial of lymphoma treatment at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival; | — |
Countries
China
Contacts
Public ContactNiu Ting
West China Hospital of Sichuan University
Outcome results
None listed