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Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL#a Prospective Single Arm Trial

NCT07448324•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).

Detailed Description

Marginal zone lymphoma (MZL) is a type of lymphoma that comprises three main subtypes: extranodal mucosa-associated lymphoid tissue (MALT) lymphoma, nodal MZL, and splenic MZL. Accounting for approximately 7.8% of all non-Hodgkin lymphomas (NHL), MZL is the third most common subtype, following diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Although generally considered an indolent lymphoma with a favorable overall survival prognosis, some patients still face challenges such as disease relapse or transformation into aggressive large cell lymphoma, which leads to a poor prognosis. This is a prospective, single-arm, phase II study designed to evaluate the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. Eligible patients who meet the screening criteria will enter the treatment phase and receive orelabrutinib in combination with rituximab. After 6 cycles, patients who achieve complete response (CR) will continue with orelabrutinib and rituximab for an additional 6 cycles; patients with partial response (PR) or stable disease (SD) will receive orelabrutinib combined with rituximab and lenalidomide for an additional 6 cycles; patients with progressive disease (PD) will be withdrawn from the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years, either sex.
•2. Histopathologically confirmed CD20-positive marginal zone lymphoma (including MALT, SMZL, and NMZL) with at least 1 measurable lesion.
•3. Stage III or IV disease with an indication for treatment.
•4. No prior systemic therapy. Patients may have received prior local treatment (including surgery, radiotherapy, anti-Helicobacter pylori therapy, or anti-hepatitis C therapy) if they subsequently progressed, relapsed, or were unsuitable for local therapy.
•5. ECOG performance status of 0-2.
•6. Adequate organ function meeting the following criteria:
•1. Blood count: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥75 g/L. If bone marrow involvement is present: absolute neutrophil count ≥1.0×10⁹/L, platelets ≥50×10⁹/L, hemoglobin ≥50 g/L.
•2. Blood chemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN; serum amylase ≤ULN.
•7. Coagulation: International normalized ratio (INR) ≤1.5×ULN.
•8. Expected survival ≥12 months.
+1 more criteria

Exclusion Criteria

•1. Current or history of other malignancies, unless treated with curative intent and without evidence of recurrence or metastasis within the past 5 years.
•2. Central nervous system involvement or transformation to high-grade lymphoma.
•3. Uncontrolled or significant cardiovascular diseases, including:
•1. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first study drug dose, or arrhythmia requiring treatment at screening; left ventricular ejection fraction (LVEF) \<50%.
•2. Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).
•3. History of clinically significant QTc interval prolongation, or QTc interval \>470 ms (female) or \>450 ms (male) at screening.
•4. Symptomatic coronary artery disease or subjects requiring medication for it.
•5. Poorly controlled hypertension (defined as failure to achieve target blood pressure after ≥1 month of lifestyle modification combined with an adequate, tolerable regimen of ≥3 antihypertensive drugs including a diuretic, or requiring ≥4 antihypertensive drugs for control).
•4. Active bleeding within 2 months prior to screening, current use of anticoagulants, or any condition deemed by the investigator to indicate a clear bleeding tendency.
•5. History of deep vein thrombosis or pulmonary embolism within the past 6 months.
+8 more criteria

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

April 1, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2030

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Marginal Zone Lymphoma(MZL)

Interventions

Orelabrutinib

DRUG

Rituximab

DRUG

Lenalidomide

DRUG

Contacts

Lei Fan, PhD, MD

CONTACT

+86 13813976136 fanlei3014@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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