Actively Recruiting
Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-27
69
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.
CONDITIONS
Official Title
Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Cohort A: Age 18-70 years and physically fit for chemotherapy; for Cohort B: Age 70 or older, or under 70 but unfit for chemotherapy
- Gender is not restricted
- Histologically confirmed marginal zone lymphoma including MALT, SMZL, or NMZL
- Disease progression, recurrence after local treatment, or unsuitable for local treatments such as surgery, radiotherapy, or infection-targeted therapy
- ECOG performance status between 0 and 3, with score 3 allowed if due to tumor burden
- Indications for treatment including B symptoms, blood cell decline, bleeding, large mass, or rapid tumor progression
- Adequate major organ function including blood counts, liver and kidney function, and coagulation parameters
- Life expectancy of at least 3 months
- Able and willing to provide written informed consent before screening
You will not qualify if you...
- Current or past other malignant tumors unless treated with no recurrence or metastasis for at least 5 years
- Lymphoma involving the central nervous system or transformed to a higher grade
- Uncontrolled or significant cardiovascular diseases including recent heart failure, unstable angina, myocardial infarction, or arrhythmias requiring treatment
- Primary cardiomyopathies
- History of significant QTc prolongation or abnormal QTc interval during screening
- Symptomatic or medication-requiring coronary artery disease
- Uncontrolled hypertension despite adequate medication
- Active bleeding within 2 months or current use of anticoagulants
- History of deep vein thrombosis or pulmonary embolism within 6 months
- Significant gastrointestinal disorders affecting drug absorption or prior total gastrectomy
- History of organ or bone marrow transplantation
- Recent major surgery within 6 weeks or minor surgery within 2 weeks before screening
- Active infections including uncontrolled hepatitis B, hepatitis C, HIV/AIDS, or other serious infections
- Lung diseases seriously affecting function such as pulmonary fibrosis or drug-related pneumonia
- Prior treatment with BTK or related pathway inhibitors
- Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing age
- Continuous use of drugs strongly affecting cytochrome P450 CYP3A
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital ，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
X
Xuewu Zhang
CONTACT
W
Wenjuan Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here