Actively Recruiting
Orelabrutinib for the Treatment of Marginal Zone Lymphoma A Phase II, Multicenter, Open-label Study
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
30
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
B
Beijing Tongren Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Marginal zone lymphoma MZL is a slow-growing cancer that affects a type of white blood cell called B lymphocytes, mainly found in areas like the spleen, lymph nodes, and mucosa-associated lymphoid tissues. This research evaluates the drug orelabrutinib, a new and highly selective inhibitor of Bruton tyrosine kinase BTK, in patients with early-stage, previously untreated MZL. The study aims to explore both the effectiveness and safety of orelabrutinib, addressing the need for treatments with better outcomes and fewer side effects compared to existing options like ibrutinib. Participants will receive orelabrutinib at a dose of 150 mg daily during an induction phase consisting of six treatment cycles, each lasting 28 days. After completing the induction phase, patients enter a follow-up period where their health and response to treatment are monitored. This multicenter phase II trial is open-label and focuses on treatment-nave MZL patients. Throughout the study, researchers will assess response rates, time to response, duration of response, progression-free survival, overall survival, and any adverse events. These evaluations will occur from the start of treatment through the induction and follow-up periods, lasting up to two years for some measures. Participants will undergo regular clinical assessments, laboratory tests, and monitoring to track the effects and safety of orelabrutinib.
CONDITIONS
Brief Title
Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histopathologically confirmed stage I or II marginal zone lymphoma
- ECOG performance status score of 0 to 2
- Adequate organ function as defined by blood counts, liver and kidney tests
- International normalized ratio (INR) less than or equal to 1.5 times the upper limit of normal
- Expected survival time of at least 12 months
- Signed voluntary informed consent before trial screening
You will not qualify if you...
- Lymphoma involving the central nervous system or transformation to high-grade lymphoma
- Uncontrolled or significant cardiovascular diseases including congestive heart failure class II or higher, unstable angina, recent myocardial infarction, or arrhythmia needing treatment
- Primary cardiomyopathy of any type
- History of clinically significant QTc interval prolongation or prolonged QTc at screening
- Symptomatic coronary artery disease requiring medication
- Poorly controlled hypertension despite treatment
- Active bleeding within 2 months prior to screening or current use of anticoagulants
- History of deep vein thrombosis or pulmonary embolism within 6 months
- Urine protein 2+ or higher and 24-hour urine protein over 2 grams
- Gastrointestinal issues affecting drug intake or absorption, including total gastrectomy
- Lung conditions affecting function such as fibrosis or pneumonia
- Pregnant or breastfeeding women or unwillingness to use contraception if of childbearing potential
- Continuous use of drugs strongly affecting cytochrome P450 CYP3A
- Other conditions deemed unsuitable by the investigator for trial participation
Research Team
S
Shuhua Yi
L
Liang Wang
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