Health TrialsbyHealthPanel

Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL

ConditionsInitial MZLUntreated MZLBTKiCD20
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ZO

    Drug

    Orelabrutinib 150mg, po, gd, D1-D28, every 28 days, cycle 1-12; Zuberitamab: intravenously administered on day 1 of the cycle at a dose of 375mg/m2 every 28 days, once every cycle for cycles 1-6 and once every 2 cycles for cycles 7-12.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Trial groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1Y CRR

Complete response rate (CR) at the end of combination therapy Efficacy evaluation was performed every 3 cycles (12 weeks) during the treatment period, every 3 months during the maintenance treatment period, and every 3-6 months during the observation and follow-up period, using Lugano 2014 efficacy evaluation criteria. MRD tests are performed every 6 cycles within 2 years of starting the drug.For the main efficacy indicators, complete response rate (CR) and 95%CI were calculated.

Time frame
2 years

Secondary outcomes

1

uMRD

Undetectable rate of total minimal residual lesions For the secondary efficacy indicators, such as 24-month progression-free survival (DFS) and 24-month overall survival (GFS), kaplan-Meier method was used to estimate and 95%CI were calculated, and survival curves were drawn. For secondary efficacy measures, uMRD, ORR and 95%CI were calculated.

Time frame
2 years
2

ORR

Objective response rate

Time frame
2 years
3

PFSR in 24m

24-month progression-free survival

Time frame
2 years
4

OSR in 24m

24-month overall survival

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Li Zhiming

Lead sponsor

Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov
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