Actively Recruiting
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy
Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-07-29
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
T
The First Hospital of Jilin University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma
CONDITIONS
Official Title
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL
- Indications for treatment such as impact on organ function, lymphoma-related symptoms, large masses, or hematopenia secondary to lymphoma
- Marginal zone lymphoma that has progressed, relapsed, or is unsuitable for local therapy after prior local treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- At least one measurable or evaluable lesion according to Lugano 2014 criteria by PET/CT or CT/MR imaging, or histologically confirmed bone marrow infiltration for splenic MZL
- Concealed carriers of HBV with negative HBV-DNA test eligible
- Adequate major organ function defined by blood counts, blood biochemistry, and coagulation function
- Expected survival of at least 3 months
- Voluntary written informed consent before screening
You will not qualify if you...
- Lymphoma involving the central nervous system or high-grade transformation
- HIV-positive or active hepatitis C infection
- History of deep vein thrombosis or pulmonary embolism within the last 6 months
- Active bleeding within 2 months prior to screening or use of anticoagulant medication
- Continuous use of drugs that strongly affect cytochrome P450 CYP3A
- Severe chronic obstructive pulmonary disease with hypoxemia
- Active uncontrolled bacterial, fungal, or viral infections
- Other malignant tumors within the last 2 years except certain early-stage cancers
- Uncontrolled or significant cardiovascular disease including NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, primary cardiomyopathies, prolonged QTc interval, symptomatic coronary artery disease, or difficult-to-control high blood pressure
- Clinically significant gastrointestinal abnormalities interfering with drug intake or absorption
- Major surgery within 6 weeks or minor surgery within 2 weeks before screening
- Use of drugs or alcohol
- Pregnant or lactating females or those not willing to use contraception
- Known allergy to murine antibodies or proteins
- Any mental or cognitive impairment limiting informed consent compliance
- Previous treatment with BTK, BCR pathway inhibitors, or BCL-2 inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bing, Xu
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
B
Bing Xu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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