Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.

Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve Marginal Zone Lymphoma: A Study of Efficacy and Safety.

NCT07372365•The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

This study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. The current standard treatment involves chemotherapy, but it can have significant side effects and may not always provide long-term benefits. This study investigates a treatment strategy that combines a limited course of chemotherapy (R-CHOP) followed by consolidation and maintenance therapy with a targeted drug called Orelabrutinib. Patients will undergo a series of tests to determine eligibility for the study. These tests include blood work, imaging studies, and assessments of overall health. Eligible participants will receive a standard chemotherapy regimen called R-CHOP for three cycles. After this, the response to treatment will be evaluated. Participants who show a good response will then receive three cycles of consolidation therapy with Orelabrutinib and Rituximab (OR). Those who continue to respond well will enter a maintenance phase with Orelabrutinib for up to two years. Throughout the study, participants will be closely monitored for treatment response and any side effects. Regular check-ups, blood tests, and imaging studies will be conducted to assess the effectiveness and safety of the treatment. This study is an important step towards finding better treatment options for MZL patients. It is hoped that through this research, the quality of life and outcomes for those affected by this disease can be improved.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received systemic therapy.
•2. MZL that has progressed or relapsed after prior local therapy (local therapy includes surgery, radiotherapy, Helicobacter pylori eradication, and hepatitis C treatment) or is not amenable to local therapy.
•3. Age ≥18 years.
•4. Presence of an indication for treatment as determined by the investigator or patient's willingness to receive treatment.
•5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
•6. Adequate organ function as defined below:
•* Hematology: Hemoglobin (HB) ≥60 g/L, platelets (PLT) ≥50×10⁹/L, neutrophils (NE) ≥1.0×10⁹/L (Note: Subjects with cytopenia due to lymphoma bone marrow involvement are not restricted by this criterion).
•* Cardiac: Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiogram.
•* Renal: Creatinine ≤1.5×upper limit of normal (ULN) or creatinine clearance ≥30 ml/min.
•* Hepatic: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN.
+3 more criteria

Exclusion Criteria

•1. Underwent major surgery or severe trauma within 2 weeks prior to enrollment, or has not yet recovered from significant adverse effects.
•2. Has other malignancies currently or within the past 3 years, excluding those that have been cured (such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ).
•3. Has a history of stroke or intracranial hemorrhage within the past 3 months.
•4. Requires anticoagulation with warfarin or equivalent vitamin K antagonist.
•5. Has evidence of any comorbidities or medical conditions that may interfere with the conduct of the study or place the patient at significant risk, including but not limited to severe cardiovascular disease (e.g., New York Heart Association class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) and/or severe pulmonary disease (e.g., severe obstructive pulmonary disease and a history of symptomatic bronchospasm).
•6. Is infected with human immunodeficiency virus, or has uncontrollable active hepatitis C virus or hepatitis B virus infection.
•7. Has uncontrollable active infection.
•8. Is pregnant or breastfeeding.
•9. Has any life-threatening disease, medical condition, or organ dysfunction that may jeopardize the safety of the patient, as determined by the investigator.
•10. Has any condition that may interfere with the absorption or metabolism of orelabrutinib or place the study results at unnecessary risk.
+2 more criteria

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

October 24, 2025

Primary Completion Date

April 1, 2028

Completion Date

October 1, 2030

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Marginal Zone Lymphoma (MZL)

Interventions

Orelabrutinib Consolidation and Maintenance Therapy

DRUG

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ENROLLING_BY_INVITATIONPHASE1

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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: January 28, 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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Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.

Inclusion Criteria

Exclusion Criteria

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)

Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP