Prospective, Multicenter, Single-arm Clinical Study of Orelabrutinib Plus Rituximab for Second-line Treatment of Relapsed/Refractory Marginal Zone Lymphoma

Lixia Sheng3 sites in 1 country39 target enrollmentJanuary 2, 2023

ConditionsOR Regimen for Relapsed/Refractory Marginal Zone Lymphoma

InterventionsOrelabrutinib combined with rituximab

DrugsOrelabrutinib combined with rituximab

Overview

Phase: Phase 4
Intervention: Orelabrutinib combined with rituximab
Conditions: OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma
Sponsor: Lixia Sheng
Enrollment: 39
Locations: 3
Primary Endpoint: Objective Response Rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.

Registry

clinicaltrials.gov

Start Date

January 2, 2023

End Date

December 31, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lixia Sheng

Responsible Party

Sponsor Investigator

Principal Investigator

Lixia Sheng

hematology department

Ningbo No. 1 Hospital

Eligibility Criteria

Inclusion Criteria

•Age: 18 years, 80, Sex gender no limitied;
•histological confirmation of MZL, For splenic marginal zone lymphoma (SMZL) where histological specimens of the spleen were not available, Requirements to meet the minimum diagnostic criteria for SMZL, And exclude any other type of small B cell lymphoma, That is, requiring a definite diagnosis of MZL;
•at least one two-dimensional measurable lymph node lesion (CT scan or MR / display maximum diameter\> 1.5cm), Or at least one two-dimensional measurable extranodal lesion (CT scan or MRI showing maximum diameter\> 1.0cm);
•the investigator required systemic treatment for marginal zone lymphoma;
•at least 1 previous course of systemic lymphoma treatment (including previous immunotherapy or chemoimmunotherapy), 3 without efficacy above PR after imaging evaluation, Or disease progression after effective treatment;
•ECOG, physical strength score 0-2;
•primary organ function meets the following criteria 7 days prior to treatment:
•blood routine: absolute neutrophil ≥1.5x10\^9 / L, Platelet≥ 75x10\^9 / L, Hemoglobin≥75g / L; If the concomitant bone marrow invasion, Absolute neutrophil value ≥1.0x10\^9 / L, Platelet≥50x10\^9 / L, Hemoglobin≥ 50g / L;
•Blood Chemistry: total bilirubin ≤1.5 times ULN, AST or ALT ≤2 times ULN; If the liver is infiltrated with a lymphoma, Then, ALT and AST ≤5 times ULN, Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥45 ml/min (Cockcroft-Gault formula); Serum amylase ≤ULN;
•coagulation function: International normalized ratio (INR) ≤1.5 times ULN, Activated partial thromboplastin time (APTT)≤ 1.5 times ULN.

Exclusion Criteria

•The patient had been previously treated with obutinib in combination with rituximab, Efficacy was assessed as being refractory, Infraciness was defined as no remission (PR or CR) after start of treatment 4
•history of severe allergy or allergic reaction to monoclonal antibody therapy
•known to be allergic to any study drug
•current or previous other malignancy, Unless curative treatment with no evidence of recurrence and metastasis in nearly 5 years;
•lymphoma involvement of the central nervous system;
•uncontrolled or important cardiovascular disease, Includes:
•occurrence of New York Cardiology Association (NYHA) grade II or above congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of study drug, Or the presence of significant arrhythmias requiring treatment at screening (e. g., persistent rapid AF, persistent ventricular tachycardia, ventricular fibrillation, tip torsion, history of second-degree II AV (AV) block, or history of third-degree AV block), Left ventricular ejection fraction (LVEF) \<50%;
•primary cardiomyopathy (e. g. dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, irregular cardiomyopathy);
•history of clinically significant QTc interval extension, Or subjects with coronary heart disease with QTc interval female\> 470ms and male\> 450ms;
•symptomatic or requiring medication;

Arms & Interventions

OR regimen

The specific medication regimen for the OR regimen is as follows: Orelabrutinib 150mg orally once daily; Rituximab 375mg/m² intravenous infusion, administered every 21 days.

Intervention: Orelabrutinib combined with rituximab

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: up to 8 months

Proportion of CR and PR subjects will be assessed at 8 courses

Secondary Outcomes

Overall survival(up to36 months)
Adverse events profile(Measured from start of treatment until 21 days after last dose)
Progress free survival time(up to36 months)