Actively Recruiting
Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-01-28
23
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received systemic therapy.
- MZL that has progressed or relapsed after prior local therapy or is not suitable for local therapy.
- Age 18 years or older.
- Indication for treatment as determined by the investigator or patient's willingness to receive treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Adequate organ function including hemoglobin ≥60 g/L, platelets ≥50×10⁹/L, neutrophils ≥1.0×10⁹/L (except for cytopenia due to lymphoma bone marrow involvement), left ventricular ejection fraction ≥50%, creatinine ≤1.5× upper limit of normal or creatinine clearance ≥30 ml/min, and AST and ALT ≤3× upper limit of normal.
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during treatment and for 2 years thereafter.
- Life expectancy of more than 3 months.
- Voluntary written informed consent.
You will not qualify if you...
- Major surgery or severe trauma within 2 weeks before enrollment or not recovered from adverse effects.
- Other malignancies within the past 3 years except cured basal or squamous cell skin carcinoma, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ.
- History of stroke or intracranial hemorrhage within the past 3 months.
- Requirement for anticoagulation with warfarin or equivalent vitamin K antagonist.
- Severe cardiovascular disease or severe pulmonary disease.
- Infection with HIV or uncontrollable active hepatitis C or B virus.
- Uncontrollable active infection.
- Pregnancy or breastfeeding.
- Life-threatening disease, medical condition, or organ dysfunction posing safety risks.
- Conditions interfering with absorption or metabolism of orelabrutinib or study results.
- Central nervous system involvement by MZL or disease transformation.
- Conditions interfering with full participation or posing significant safety risks as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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