Actively Recruiting
Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma
Led by Beijing Tongren Hospital · Updated on 2026-01-21
88
Participants Needed
3
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody. This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups: 1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy. Sample size: 50 cases. 2. Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 \[C1\], and on Day 1 of Cycles 2-6 \[C2-C6\]). Target population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy. Sample size: 38 cases.
CONDITIONS
Official 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 60; 18 years
- Pathologically confirmed marginal zone lymphoma
- Presence of evaluable lesions
- Meets treatment indications: GELF criteria or disease-related symptoms/organ function impairment
- Unsuitable for or refuse local radiotherapy, or disease progression after local therapy
- Includes patients with Stage I gastric MALT MZL who are H. pylori-negative or have poor response to H. pylori eradication
- Includes patients with non-gastric MALT and nodal MZL at non-contiguous Stage II or Stage III-IV
- Includes splenic marginal zone lymphoma (SMZL) patients
- Includes gastric MALT classified as Lugano II2, IIE, or IV stage
- 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...
- Currently diagnosed with another malignant tumor
- Lymphoma involving the central nervous system or transformation to higher grade
- Allergy to any study drugs
- Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infections
- Pregnancy, lactation, or unwillingness to use contraception if of childbearing potential
- Other conditions deemed unsuitable by the investigator
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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
CONTACT
W
Wei Zhang, MD
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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