Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLi Zhiming
About this trial
This is a multi-center, prospective cohort study. The main purpose of study is to evaluate the efficacy and safety of Orelabrutinib combined with Zuberitamab in the initial treatment of MZL Main efficacy indicators Complete response rate (CR) at the end of combination therapy.
Eligibility criteria
Qualifiers
ANC>1.0×109/L;
PLT>75×109/L (≥50×109/L for patients with confirmed bone marrow infiltration);
Hb>80g/dL;
TBIL<2×ULN;
Disqualifiers
Patients with central nervous system invasion;
Previous or co-existing uncured malignancies, except cured skin basal cell MZL clinical trial protocol cancer, 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 2450 ms for men and 2470 ms for women); According to NYHA standards, patients with grade III to V cardiac insufficiency or left ventricular ejection fraction (LVEF) <50% indicated by cardiac color ultrasound;
Abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), have a tendency to hemorrhage or are receiving thrombolytic or anticoagulant therapy;
Trial design
Treatments tested in this trial
- ZO
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Li Zhiming
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov