Tests zanubrutinib added to chemotherapy for lymphoma that has spread to the brain
Tests chemotherapy with or without zanubrutinib in adults with newly diagnosed large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06594432, who can take part
Where in China
- Hematological Department, People's Hospital of Jiangsu ProvinceNanjing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT06594432
- Record updated
- 19 September 2024
- Original description
Evaluate the Efficacy and Safety of R-CHOP-MTX±Zanubrutinib in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with Central Nervous System Involvement, and Explore the Efficacy Indicators of CSF-ctDNA.Read full original descriptionShow less
A Study on the Efficacy and Safety of Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement
Evaluate the Efficacy and Safety of R-CHOP-MTX±Zanubrutinib in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with Central Nervous System Involvement, and Explore the Efficacy Indicators of CSF-ctDNA.
Inclusion: Age ≥18 years and ≤80 years, regardless of gender; Patients with pathologically confirmed, previously untreated diffuse large B-cell lymphoma (DLBCL) who are CSF-ctDNA positive for secondary CNS lymphoma (SCNSL); MRI or CT of the brain showing substantial lesions in the central nervous system; patients with only meningeal lesions must have CSF cytology confirming lymphoma cells and/or imaging findings consistent with CSF examination; Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3; Organ function levels meeting the following requirements:Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L (if bone marrow is involved, platelets ≥50×10\^9/L); Liver function: ALT and AST ≤2.5 times the upper limit of normal, total bilirubin ≤2 times the upper limit of normal; 8.Renal function: creatinine ≤1.5 times the upper limit of normal; creatinine clearance rate ≥40 ml/min (assessed according to the Cockcroft-Gault formula or the estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD] formula); 9.Coagulation function: International Normalized Ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN; 10.Expected survival time \>3 months; 11.No radiotherapy, chemotherapy, or antibody therapy within 3 weeks before medication; no targeted therapy within 10 days before medication; 12.Female subjects of childbearing potential must agree to use effective contraception during the study and for at least 90 days after the last dose of the study drug. Male subjects must be sterilized, i.e., vasectomy, or use barrier methods, while their female partners use the aforementioned effective contraception; 13.Signed written informed consent before trial screening.
Exclusion: Previous treatment with BTK inhibitors; Received targeted therapy within 10 days before starting the study drug, or systemic chemotherapy, radiotherapy, or antibody therapy within 3 weeks before starting the study drug; Currently have clinically significant active cardiovascular disease, such as uncontrolled arrhythmias, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 6 months before screening; Patients with active infections or persistent fever within 14 days before enrollment (excluding tumor-related fever); Patients who have not completed 4 weeks after major organ surgery; Patients receiving strong inhibitors or strong inducers of cytochrome P450 family 3 subfamily A (CYP3A); Patients who abuse drugs or have long-term alcoholism that affects the evaluation of trial results; Patients with active bleeding; Patients with active HBV, HCV, and HIV infections; Patients with mental disorders/unable to obtain informed consent; Abnormal liver function (total bilirubin \>2 times the normal value, ALT or AST \>2.5 times the normal value), abnormal renal function (serum creatinine \>1.5 times the normal value); Previous chemotherapy with unresolved toxicity (toxicity not resolved to ≤ grade 1 according to NCI-CTCAE 5.0, except for alopecia, absolute neutrophil count (ANC), and platelets); QTcF \>450 msecs or other significant ECG abnormalities, including second-degree type II atrioventricular (AV) block or third-degree AV block; Patients with serous cavity effusion; Pregnant or lactating women and patients of childbearing potential who are unwilling to use contraception; Patients deemed unsuitable for participation in this study by the investigator.