Mantle cell lymphoma
Conditions
Interventions
Treatment group:Zanubrutinib Combined with Obinutuzumab & CHOP Regimen
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed and untreated mantle cell lymphoma (MCL) according to World Health Organization (WHO) classification; 2.Age >= 18 years old and = 1×10^9/L Platelet count >= 75×10^9/L (platelet count >= 50×10^9/L if bone marrow involvement) Aminotransferases (aspartate aminotransferase AST and alanine aminotransferase ALT) = 30 mL/ min; 7.The international normalized ratio (INR) was 3 months;
Exclusion criteria
Exclusion criteria: 1.Central nervous system (CNS) involvement is known to be present in mantle cell lymphoma (MCL). 2.Surgery within 4 weeks prior to screening; 3.Previous hematopoietic stem cell transplantation; 4.Concomitant other concurrent or prior malignancies within the past 2 years; 5.Presence of clinically significant cardiovascular disease such as uncontrolled arrhythmia and hypertension, congestive heart failure, or myocardial infarction, or grade 3 (moderate) or 4 (severe) heart disease as defined by the New York Heart Association cardiac function grading criteria within 6 months prior to screening, or left ventricular ejection fraction (LVEF) less than 50% (AHA, 2016); 6.QTcF interval >450 msec or other significant electrocardiogram (ECG) abnormalities, including second-degree type II atrioventricular block or third-degree atrioventricular block; 7.Clinically significant hypersensitivity reaction (e.g., anaphylactic or anaphylactoid reaction) to zanubrutinib compound itself or to its excipients in its formulation; 8.Treatment with a strong CYP3A inhibitor or a strong CYP3A inducer is required; 9.Inability to swallow capsules or presence of a disease that significantly affects gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, bariatric surgery, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction; 10.Unresolved hepatitis B or hepatitis C infection or known HIV-positive infection; 11.Active infection, including infections requiring oral or intravenous antimicrobial therapy; 12.Any life-threatening disease, medical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety or put this study at risk; 13.History of stroke or intracranial hemorrhage within 6 months prior to the first administration of study drug; 14.Pregnancy or lactation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactWenjuan Yu
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed