Actively Recruiting
Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
Led by Sun Yat-sen University · Updated on 2026-01-15
42
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Zanubrutinib in combination with Rituximab as a first-line treatment for patients with mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma.
CONDITIONS
Official Title
Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma by histopathology
- Newly diagnosed with Ann Arbor stage III-IV or relapsed MALT after local treatment
- No prior systemic anti-lymphoma therapy except H. pylori eradication therapy for H. pylori-positive gastric MALT
- No histopathological transformation to high-grade lymphoma
- At least one measurable lesion according to Lugano 2014 criteria
- Age 18 years or older, any gender
- ECOG performance status score of 0-2
- Expected survival time greater than 12 months
- Adequate bone marrow, cardiac, pulmonary, liver, and kidney function
- Willing and able to participate in the clinical study with informed consent and comply with all study procedures
You will not qualify if you...
- History of stroke, intracranial hemorrhage, or warfarin use within the past 6 months
- Central nervous system involvement
- Prior allogeneic hematopoietic stem cell transplantation
- Previous use of BTK inhibitors or CD20 monoclonal antibody therapy
- Active infections except tumor-related B-symptom fever
- Concurrent history of other malignancies except cured cervical carcinoma in situ or basal cell carcinoma of the skin
- Use of potent cytochrome P450 inhibitors
- Severe cardiovascular diseases such as uncontrolled arrhythmias, congestive heart failure, or myocardial infarction within the past 12 months
- Significant organ dysfunction or uncontrollable comorbidities posing safety risk or absorption/metabolism issues with Zanubrutinib
- Pregnant or breastfeeding women and women of childbearing age unwilling to use contraception
- Anti-tumor therapy within 4 weeks before enrollment
- Active chronic hepatitis B or hepatitis C
- Systemic corticosteroid or other immunosuppressive therapy within 14 days before study treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China, 51000
Actively Recruiting
Research Team
Q
Qingqing Cai, MD. PhD.
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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