Actively Recruiting
Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-10-06
169
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter, phase 2, non-randomized study aiming to evaluate the efficacy and safety of orelabrutinib combined with zebetuzumab and lenalidomide or bendamustine combined with rituximab in the treatment of newly diagnosed marginal zone lymphoma (MZL).
CONDITIONS
Official Title
Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Histopathologically confirmed CD20-positive marginal zone lymphoma (includes MALT, SMZL, and NMZL) with at least one measurable lesion
- Indication for treatment based on disease stage and symptoms, including specific criteria for gastric MALT, non-gastric MALT, NMZL, and SMZL
- No prior systemic treatment; may include progressed or relapsed MZL unsuitable for local treatment
- ECOG performance status of 0 to 2
- Adequate main organ function as defined by blood counts, liver and kidney function, and coagulation
- Expected survival time of at least 12 months
- Voluntary written informed consent before trial screening
You will not qualify if you...
- Current or past other malignancies unless treated with no recurrence or metastasis for 5 years, excluding certain skin and cervical cancers
- Lymphoma involving the central nervous system or transformed to a higher grade
- Uncontrolled or significant cardiovascular diseases, including severe heart failure, unstable angina, recent heart attack, cardiomyopathies, significant QTc prolongation, symptomatic coronary heart disease, or uncontrolled hypertension
- Active bleeding within 2 months, use of anticoagulants, or clear bleeding tendency
- History of deep vein thrombosis or pulmonary embolism in past 6 months
- Major surgery within 6 weeks or minor surgery within 2 weeks before screening
- Active infection or uncontrolled hepatitis B or C, HIV/AIDS, or other severe infections
- Severe lung function impairment due to various lung diseases
- Pregnancy, breastfeeding, or unwillingness to use contraception if of childbearing age
- Continuous use of medications strongly affecting cytochrome P450 CYP3A
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
J
Jianyong Li, PhD, MD
CONTACT
H
Huayuan Zhu, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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