Actively Recruiting
Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma: A Phase II, Prospective, Multicenter, Single-Arm Clinical Study
Led by Beijing Tongren Hospital · Updated on 2026-01-21
88
Participants Needed
3
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients newly diagnosed with marginal zone lymphoma (MZL), focusing on the effectiveness and safety of orelabrutinib alone or combined with a CD20 monoclonal antibody. This study addresses the lack of a standard first-line therapy for MZL and aims to explore chemotherapy-free options with fewer side effects. Orelabrutinib is a newer BTK inhibitor known for its selectivity and safety, and it may work well with CD20 antibodies. The trial includes patients at different disease stages and monitors tumor response and side effects closely. Participants receive orelabrutinib treatment in all study groups but are divided based on disease stage. Those with Stage I MZL receive orelabrutinib monotherapy, taking 150mg orally once daily for 21 days per cycle, over six cycles. Patients with Stages II to IV MZL receive orelabrutinib combined with either rituximab or obinutuzumab, given through intravenous infusions on specific days during the same six treatment cycles. A maintenance phase with orelabrutinib may follow the initial treatment cycles for the combination group. Throughout the study, participants undergo regular imaging and lab tests to evaluate tumor changes and overall response. Safety is assessed by recording all adverse reactions in detail. Long-term follow-up tracks progression-free and overall survival rates up to two years and beyond. The primary outcome is the overall response rate by the end of 21 weeks of treatment, with additional measures including complete response rate and safety monitoring over approximately 2.5 years.
CONDITIONS
Brief Title
Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed marginal zone lymphoma
- Presence of measurable lesions
- Meets treatment indications: GELF criteria or disease-related symptoms/organ impairment
- Unsuitable for local radiotherapy, refused radiotherapy, or progressed after local therapy
- Includes Stage I gastric MALT MZL patients who are H. pylori-negative or have poor response to H. pylori therapy
- Includes non-gastric MALT, nodal MZL at stages II-IV, splenic MZL, and other patients unsuitable for radiotherapy
- ECOG performance status 0-3
- Expected survival time of at least 3 months
- Ability to provide signed informed consent
You will not qualify if you...
- Current diagnosis of another malignant tumor
- Central nervous system involvement by lymphoma or transformation to higher grade
- Allergy to any investigational drugs
- Active infection or uncontrolled HBV, HIV/AIDS, or other serious infections
- Pregnancy, breastfeeding, or unwillingness to use contraception if of childbearing potential
- Any other conditions deemed unsuitable by the investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 21 weeks (6 cycles of 21 days each)
Participants receive orelabrutinib treatment either as monotherapy or combined with a CD20 monoclonal antibody. Treatment cycles last 21 days each, with a total of 6 cycles. CD20 monoclonal antibody infusions occur on specific days depending on the antibody used.
6 treatment cycles with visits for oral medication and intravenous infusions as scheduled
Duration - Up to 2 years after treatment completion
Participants are monitored long-term to assess progression-free survival, overall survival, and safety, including tracking adverse events.
Regular follow-up visits during the 2-year period
Trial Site Locations
Total: 3 locations
1
Beijing Tongren Hospital
Beijing, China
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, China
Not Yet Recruiting
3
The First Affiliated Hospital of China Medical University
Beijing, China
Not Yet Recruiting
Research Team
L
Liang Wang, MD
W
Wei Zhang, MD
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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