Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL: A Randomized, Open Phase II Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFei Li

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

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fei Li

Lead sponsor

The First Affiliated Hospital of Nanchang University

Sponsor institution