About this trial
This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL
Eligibility criteria
Qualifiers
None
Disqualifiers
Patients with central nervous system involvement;
History or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer;
Patients with the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval for males ≥450 ms, for females ≥470 ms); Class III to IV heart failure according to NYHA standards, or echocardiography indicating left ventricular ejection fraction (LVEF) <50%;
Coagulation abnormalities (INR >1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy;
Trial design
Treatments tested in this trial
- Orelabrutinib
- rituximab
- Cyclophosphamide
- Vincristine
- Prednisone tablet
Treatment groups
Sponsors and collaborators
Fei Li
Lead sponsor
The First Affiliated Hospital of Nanchang University
Sponsor institution