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

ConditionMarginal Zone Lymphoma(MZL)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Orelabrutinib

    Drug

    150mg po

  • rituximab

    Drug

    375mg/m\^2, intravenous

  • Cyclophosphamide

    Drug

    750mg/m\^2

  • Vincristine

    Drug

    1.4mg/m\^2

  • Prednisone tablet

    Drug

    60mg/m\^2

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: OR-RExperimental treatment 2 interventions
Group B: R-CVPActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

CRR

The proportion of patients who achieve Complete Remission (CR) at the end of the combined antitumor treatment

Time frame
up to two years

Secondary outcomes

1

ORR

ORR is defined as the percentage of participants with partial or complete response

Time frame
up to two years
2

PFS rate at 24month

the proportion of patients who have not experienced disease progression or death due to any cause within 2 years of receiving the first dose of the study medication.

Time frame
Two years after the last patient was enrolled.
3

Safety parameters

Type, frequency, and severity of AEs

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

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

Fei Li

Lead sponsor

The First Affiliated Hospital of Nanchang University

Sponsor institution

Source ClinicalTrials.gov
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