Actively Recruiting
Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL
Led by Li Zhiming · Updated on 2025-05-22
33
Participants Needed
2
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, prospective cohort study. The main purpose of study is to evaluate the efficacy and safety of Orelabrutinib combined with Zuberitamab in the initial treatment of MZL Main efficacy indicators Complete response rate (CR) at the end of combination therapy.
CONDITIONS
Official Title
Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status level 0 to 2
- Expected survival of at least 12 weeks
- CD20-positive marginal zone lymphoma confirmed by WHO 2008 classification, including splenic, lymph node, and extranodal subtypes
- Stage III/IV disease or stage I/II with recurrence or progression after local treatment
- Patients who have received BTK inhibitor therapy for more than 6 months are eligible
- Measurable lesions detected by enhanced CT or MRI
- Meet NCCN guidelines for MZL treatment and have not had prior systemic treatment for MZL
- Normal major organ function meeting specified blood count and biochemical criteria
- Women of childbearing potential must use reliable contraception and have a negative pregnancy test within 7 days before enrollment
- Men must use appropriate contraception or have surgical sterilization during and 8 weeks post treatment
- Voluntarily consent to participate with good compliance and follow-up
You will not qualify if you...
- Central nervous system involvement
- Previous or untreated malignancies except certain cured cancers (skin basal cell, cervical carcinoma in situ, superficial bladder cancer)
- Cardiovascular diseases including Grade II or higher myocardial ischemia or infarction, uncontrolled arrhythmias, severe cardiac insufficiency, or LVEF below 50%
- Abnormal blood clotting or bleeding tendencies or currently on thrombolytic or anticoagulant therapy
- Arteriovenous thrombosis events within 12 months prior to enrollment
- Known hereditary or acquired bleeding or clotting disorders
- Major surgery, severe trauma, fracture, or ulcer within 4 weeks before enrollment
- Conditions affecting oral drug absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Active infections requiring antimicrobial treatment (excluding certain chronic hepatitis treatments)
- Active hepatitis B or C infections above specified viral load thresholds
- History of psychotropic drug abuse or uncontrolled mental disorders
- Participation in other anti-tumor drug trials within 4 weeks before enrollment
- Use of potent CYP3A4 inhibitors within 7 days or inducers within specific days before enrollment
- Pregnant or breastfeeding women or those unwilling or unable to use effective contraception
- Other conditions deemed by investigators to affect study conduct or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 515800
Not Yet Recruiting
Research Team
Z
Zhiming Li, professor
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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