Actively Recruiting
Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial
Led by Fei Li · Updated on 2025-06-17
90
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL
CONDITIONS
Official Title
Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status between 0 and 2
- Life expectancy of at least 12 weeks
- Confirmed CD20-positive marginal zone lymphoma (splenic, nodal, or extranodal subtype) per WHO 2008 criteria
- Measurable lesions detected by enhanced CT or MRI
- Indication for treatment per NCCN guidelines with no prior systemic treatment for MZL
- Normal major organ function
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use reliable contraception during the trial and for 8 weeks after last treatment
- Men must agree to use appropriate contraception during the trial and for 8 weeks after last treatment or have undergone surgical sterilization
- Voluntary participation with signed informed consent, good compliance, and willingness to follow up
You will not qualify if you...
- Central nervous system involvement
- History or current untreated malignant tumors except cured basal cell carcinoma of skin, cervical carcinoma in situ, or superficial bladder cancer
- Cardiovascular diseases including Grade II or above myocardial ischemia or infarction, poorly controlled arrhythmias, Class III-IV heart failure, or left ventricular ejection fraction below 50%
- Coagulation abnormalities with bleeding tendency or ongoing thrombolytic/anticoagulant therapy
- Arterial or venous thrombotic events within 12 months before enrollment
- Known hereditary or acquired bleeding or thrombotic disorders
- Major surgery, severe trauma, fractures, or ulcers within 4 weeks before enrollment
- Conditions affecting absorption of oral medications such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Active infections requiring antimicrobial treatment (excluding chronic hepatitis B antiviral therapy)
- Active hepatitis B or C infection
- History of substance abuse or mental disorders preventing study compliance
- Participation in other anticancer drug trials within 4 weeks before enrollment
- Use of potent CYP3A4 inhibitors within 7 days or CYP3A4 inducers within 12 days before enrollment
- Pregnant or breastfeeding women or unwillingness/inability to use effective contraception
- Other conditions deemed by the investigator to affect study conduct or outcomes
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
Research Team
Y
Yulan Zhou Doctor, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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