Actively Recruiting
Study to Evaluate the Efficacy and Safety of Orelabrutinib Combined With Rituximab as First-line 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
104 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
Marginal zone lymphoma (MZL) is a common type of B-cell non-Hodgkin lymphoma. Researchers are evaluating the efficacy and safety of combining orelabrutinib with rituximab as a first-line systemic treatment for MZL. This is a single-arm, prospective clinical trial aiming to explore a chemotherapy-free regimen that may offer a safer alternative to intensive immunochemotherapy, which has high rates of serious side effects. The study focuses on patients with newly diagnosed MZL who need systemic therapy. All participants will receive induction treatment with orelabrutinib and rituximab over six 28-day cycles. In the first cycle, rituximab is given on Day 1. From the second to the sixth cycle, participants take oral orelabrutinib daily and receive rituximab on Day 1 of each cycle. Patients who respond partially or better will then enter a 2-year maintenance period taking orelabrutinib alone. This treatment plan is designed to assess the combined impact of these drugs over extended time. Participants will undergo various assessments during the study, including measuring overall response rate up to 6 months and monitoring complete response, duration of response, progression-free survival, and overall survival for up to 2 years. Safety and tolerability will also be evaluated throughout. The trial involves regular clinical evaluations and laboratory tests to track treatment effects and health status. Total participation may last over 2 years, including induction and maintenance phases.
CONDITIONS
Brief 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, NMZL) with at least one lesion over 1.5 cm outside the spleen
- Marginal zone lymphoma progressed or relapsed after local therapy or unsuitable for local therapy
- ECOG performance status between 0 and 2
- Indication for treatment based on symptoms, cytopenia, risk of organ damage, bulky disease, progression, or patient's choice
- Adequate major organ function including specific blood counts and liver, kidney, and coagulation parameters
- Life expectancy of at least 3 months
- Voluntary written informed consent obtained before screening
You will not qualify if you...
- Current or previous other malignancies unless no recurrence/metastasis for 5 years after curative treatment
- Central nervous system involvement or transformation to high-grade lymphoma
- Non-hematological toxicities from prior cancer treatments not recovered to Grade 1 or less (except hair loss)
- Significant cardiovascular disease including NYHA Class II or higher heart failure, recent heart attack, unstable angina, arrhythmias needing treatment, or low heart function
- Primary cardiomyopathy of any type
- History of significant QTc interval prolongation
- Symptomatic or treated coronary artery disease
- Uncontrolled hypertension despite medication
- Active bleeding within 2 months, use of anticoagulants, or bleeding tendency
- High urine protein levels
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- History of organ or bone marrow transplantation
- Recent major or minor surgery within specified timeframes
- Active infection or uncontrolled hepatitis B, hepatitis C, HIV/AIDS, or other serious infections
- Pulmonary conditions affecting lung function
- Previous treatment with BTK, BCR pathway, or BCL-2 inhibitors
- Planned stem cell transplantation
- Psychiatric or cognitive impairment limiting consent or compliance
- Drug abuse or alcoholism
- Pregnant, breastfeeding, or unwilling to use contraception
- Continuous use of certain drugs affecting cytochrome P450 CYP3A
- Any other condition judged unsuitable by the investigator
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 6 months (6 cycles of 28 days each)
Participants receive induction treatment with orelabrutinib combined with rituximab in 28-day cycles for a total of 6 cycles.
6 monthly visits for treatment administration and assessment
Duration - Up to 2 years
Participants who achieve a partial response or better enter a 2-year maintenance period receiving orelabrutinib.
Regular visits as per protocol during maintenance
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
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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