Actively Recruiting
Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-06-15
51
Participants Needed
18
Research Sites
235 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
T
The Second Affiliated Hospital of Jiaxing University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.
CONDITIONS
Official Title
Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, and NMZL
- At least one lesion outside the spleen larger than 1.5 cm
- MZL progressed or relapsed after local therapy or not suitable for local therapy
- ECOG performance status between 0 and 2
- Indication for treatment as judged by investigator (symptoms, cytopenia, risk of organ damage, bulky disease, progression, or patient desire)
- Adequate bone marrow, liver, kidney, and coagulation function as specified
- Life expectancy of at least 3 months
- Provided voluntary written informed consent before screening
You will not qualify if you...
- Other malignancies within past 5 years unless no recurrence or metastasis after curative treatment
- Lymphoma involvement in central nervous system or transformation to high-grade lymphoma
- Unrecovered non-hematological toxicities from previous cancer treatments (except alopecia)
- Significant or uncontrolled cardiovascular disease including heart failure NYHA class II or above, recent myocardial infarction, arrhythmias needing treatment, LVEF below 50%, primary cardiomyopathy
- History of serious QTc prolongation or high QTc interval during screening
- Symptomatic or medically treated coronary artery disease
- Uncontrolled hypertension despite medication
- Active bleeding within 2 months or use of anticoagulants or bleeding tendency
- High urine protein or recent deep vein thrombosis or pulmonary embolism
- History of organ or bone marrow transplantation
- Recent major or minor surgery within specified timeframes
- Active infections including uncontrolled hepatitis B or C, HIV/AIDS, or severe infections
- Lung diseases significantly affecting function
- Previous treatment with BTK, BCR pathway, or BCL-2 inhibitors
- Preparation for stem cell transplantation
- Psychiatric or cognitive impairments affecting consent or compliance
- Drug abuse or alcoholism
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Need for continuous use of strong CYP3A affecting drugs
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
2
Dongyang People's Hospital
Dongyang, China
Actively Recruiting
3
Affiliated Hangzhou First People's Hospital
Hangzhou, China
Actively Recruiting
4
Zhejiang cancer Hospital
Hangzhou, China
Actively Recruiting
5
Huzhou Central Hospital
Huzhou, China
Actively Recruiting
6
Affiliated Hospital of Jiaxing University
Jiaxing, China
Actively Recruiting
7
The Second Affiliated Hospital of Jiaxing University
Jiaxing, China
Actively Recruiting
8
Lishui central Hospital
Lishui, China
Actively Recruiting
9
the Affiliated Peopele'S Hospital of Ningbo University
Ningbo, China
Actively Recruiting
10
Quzhou People's Hospital
Quzhou, China
Actively Recruiting
11
Shaoxing Central Hospital
Shaoxing, China
Actively Recruiting
12
shaoxing People's Hospital
Shaoxing, China
Actively Recruiting
13
Taizhou Central Hospital
Taizhou, China
Actively Recruiting
14
Taizhou First People's Hospital
Taizhou, China
Actively Recruiting
15
Taizhou Hospital ofzhejiang Province
Taizhou, China
Actively Recruiting
16
The Second Affiliated Hospital and Yuying childrens Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
17
Yuyao People's Hospital
Yuyao, China
Actively Recruiting
18
Affiliated Zhuji Hospital ofWenzhou Medical University
Zhuji, China
Actively Recruiting
Research Team
Y
yun Liang
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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