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Clinical Trials in China / NCT07441993
Recruiting Phase 2

Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL

NCT07441993 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2026-01-05
Last updated
2026-03-02

Condition(s) studied

Marginal Zone Lymphoma

Investigational drug(s) / intervention(s)

Orelabrutinib

Orelabrutinib: Induction phase (cycle 1-6): Orelabrutinib (150 mg)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years, regardless of gender; 2. Patients with histopathologically confirmed stage I/II marginal zone lymphoma; 3. ECOG performance status score of 0-2; 4. Major organ functions meeting the following criteria: 1. Blood tests: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; 2. Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN; 5. Coagulation function: International normalized ratio (INR) ≤1.5×ULN; 6. Expected survival time ≥12 months; 7. Voluntary written informed consent signed before trial screening. Exclusion Criteria: 1. Lymphoma involving the central nervous system or transformation to high-grade; 2. 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 dose of the study drug, or arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) \<50%; 2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy); 3. History of clinically significant QTc interval prolongation, or QTc interval \>470 ms for females or \>450 ms for males at screening; 4. Subjects with symptomatic coronary artery disease requiring medication; 5. Poorly controlled hypertension (failure to achieve target blood pressure after at least one month of lifestyle modification and treatment with three or more antihypertensive drugs, including diuretics, at maximally tolerated doses, or requiring four or more antihypertensive drugs for effective control). 3. Active bleeding within 2 months prior to screening, or current use of anticoagulants, or investigator-determined clear bleeding tendency; 4. History of deep vein thrombosis or pulmonary embolism within the past six months; 5. Urine protein ≥2+ and 24-hour urine protein quantification ≥2 g/24 hours; 6. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or subjects with total gastrectomy; 7. Current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions affecting lung function; 8. Pregnant or breastfeeding women, or subjects of childbearing potential unwilling to use contraception; 9. Continuous use of drugs with moderate to strong cytochrome P450 CYP3A inhibition or strong induction effects; 10. Other conditions deemed by the investigator as unsuitable for participation in this trial.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Xiangyang Central Hospital Xiangyang Hubei Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Recruiting
Jiangsu Province People's Hospital Nanjing Jiangsu Recruiting
Affiliated Hospital of Nantong University Nantong Jiangsu Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
The First Bethune Hospital of Jilin University Changchun Jilin Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shandong Cancer Hospital & Institute Jinan Shandong Recruiting
Shandong Provincial Hospital Jinan Shandong Recruiting
Beijing Tongren Hospital, Capital Medical University Beijing China Recruiting
Hematology Hospital, Chinese Academy of Medical Sciences Tianjin China Recruiting

More Institute of Hematology & Blood Diseases Hospital, China trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441993 on ClinicalTrials.gov ↗ ← All trials in China