Actively Recruiting
Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL Single-arm, Multicenter Phase II Clinical Study
Led by Li Zhiming · Updated on 2025-05-22
33
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Marginal Zone Lymphoma (MZL) is a type of B-cell cancer found in areas like the spleen, lymph nodes, and mucosa-associated lymphoid tissues. Researchers are evaluating the combination of two drugs, Orelabrutinib and Zuberitamab, to see how well and how safely they work as the first treatment for MZL. This study is a multi-center, prospective cohort trial focusing on the complete response rate after treatment. Participants receive six cycles of induction therapy with Orelabrutinib and Zuberitamab given together. After this, patients continue with the combination therapy every two cycles for another six cycles, unless the disease worsens or side effects become intolerable. Orelabrutinib is taken orally daily, and Zuberitamab is administered intravenously on specific days of the treatment cycles. During the study, participants undergo imaging tests like CT or MRI scans to measure treatment response. Researchers monitor safety and record outcomes such as the one-year complete response rate and other measures over two years. The study involves regular assessments to track disease status, side effects, and overall health, with participation lasting through the full treatment and follow-up periods.
CONDITIONS
Brief 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 time of at least 12 weeks
- Confirmed CD20-positive marginal zone lymphoma according to WHO 2008 classification, including splenic, lymph node, and extranodal subtypes
- Stage III/IV disease or stage I/II disease 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
- No prior systemic treatment for MZL, except anti-infective treatments
- Normal main organ functions meeting blood and biochemical examination standards
- Women of childbearing age must use reliable contraception and have a negative pregnancy test within 7 days before enrollment
- Men must agree to use appropriate contraception or have surgical sterilization during the trial and 8 weeks after last dose
- Voluntary participation with signed informed consent and ability to comply with study requirements
You will not qualify if you...
- Central nervous system involvement
- Previous or ongoing untreated malignancies, except certain cured skin, cervical, or bladder cancers
- Cardiovascular diseases including grade II or higher myocardial ischemia or infarction, poorly controlled arrhythmias, severe cardiac insufficiency, or low left ventricular ejection fraction
- Abnormal blood clotting or bleeding disorders, or current use of anticoagulants
- Arteriovenous thrombosis events within 12 months prior to enrollment
- Known hereditary or acquired bleeding or clotting disorders
- Major surgery, severe injury, fracture, or ulcer within 4 weeks before enrollment
- Conditions affecting oral drug absorption, such as inability to swallow or intestinal obstruction
- Active infections requiring antimicrobial treatment, excluding some chronic hepatitis treatments
- Active hepatitis B or C infection with high viral load
- History of psychotropic drug abuse or untreated mental disorders
- Participation in other anti-tumor drug trials within 4 weeks before enrollment
- Recent use of potent CYP3A4 inhibitors or inducers within specified timeframes
- Pregnant or breastfeeding women, or unwillingness/inability to use effective contraception
- Other conditions that may affect study participation or outcomes as determined by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive Orelabrutinib combined with Zuberitamab in induction therapy for 6 cycles, followed by combination therapy every 2 cycles for up to 6 additional cycles or until disease progression or toxicity intolerance.
1 visit every 28 days during cycles 1 to 6, then 1 visit every 56 days during cycles 7 to 12
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
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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