Actively Recruiting
Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
30
Participants Needed
14
Research Sites
151 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
This is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.
CONDITIONS
Official 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 between 0 and 2
- Adequate blood counts: ANC 1.5x10^9/L, platelets 75x10^9/L, hemoglobin 75 g/L; with bone marrow involvement, ANC 1.0x10^9/L, platelets 50x10^9/L, hemoglobin 50 g/L
- Blood biochemistry within limits: total bilirubin 1.5x upper normal limit, AST or ALT 2x upper normal limit, serum creatinine 1.5x upper normal limit
- Coagulation function INR 1.5x upper normal limit
- Expected survival of at least 12 months
- Signed voluntary informed consent before screening
You will not qualify if you...
- Lymphoma involving the central nervous system or transformed to high-grade lymphoma
- Uncontrolled or significant cardiovascular disease including NYHA Class II or higher heart failure, recent myocardial infarction, arrhythmia requiring treatment, or LVEF below 50%
- Primary cardiomyopathy such as dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy
- History of significant QTc interval prolongation or abnormal QTc values at screening
- Symptomatic coronary artery disease needing medication
- Poorly controlled hypertension despite treatment
- Active bleeding within 2 months before screening or current use of anticoagulants
- History of deep vein thrombosis or pulmonary embolism within the past 6 months
- Significant proteinuria (urine protein 2+ or 24-hour urine protein 2 g)
- Clinically significant gastrointestinal disorders affecting drug intake or absorption
- Current lung conditions such as fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-related 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 judged unsuitable by the investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
3
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
4
Xiangyang Central Hospital
Xiangyang, Hubei, China
Actively Recruiting
5
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
6
Jiangsu Province People's Hospital
Nanjing, Jiangsu, China
Actively Recruiting
7
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Actively Recruiting
8
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
9
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
10
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
11
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Actively Recruiting
12
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
13
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Actively Recruiting
14
Hematology Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
S
Shuhua Yi
CONTACT
L
Liang Wang
CONTACT
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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