Actively Recruiting
Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated Marginal Zone Lymphoma A Prospective Single Arm Trial
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-03-04
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of orelabrutinib with rituximab, with or without lenalidomide, in a response-adapted treatment approach for patients newly diagnosed with marginal zone lymphoma (MZL). This single-arm, phase II study aims to assess the safety and effectiveness of this combination by measuring the complete response rate after treatment. MZL is a type of lymphoma that includes several subtypes and represents about 7.8% of all non-Hodgkin lymphomas, with some patients experiencing relapse or disease progression despite generally favorable outcomes. Participants will receive orelabrutinib and rituximab for six cycles, each cycle lasting 21 days. After these initial cycles, patients who achieve a complete response will continue with the same combination for another six cycles. Those with partial response or stable disease will receive an additional six cycles that include lenalidomide alongside orelabrutinib and rituximab. Patients whose disease progresses during treatment will discontinue the study therapy. Throughout the study, participants will be closely monitored with assessments to measure their response to treatment, including the complete response rate at the end of 12 cycles. Additional outcomes include overall response rate, progression-free survival, and overall survival over two years. The trial involves regular clinical evaluations and safety monitoring to track participant health and treatment effects, lasting until disease progression, death, or study completion.
CONDITIONS
Brief Title
Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, any sex.
- Histopathologically confirmed CD20-positive marginal zone lymphoma (including MALT, SMZL, and NMZL) with at least one measurable lesion.
- Stage III or IV disease requiring treatment.
- No prior systemic therapy; prior local treatments allowed if disease progressed or relapsed.
- ECOG performance status between 0 and 2.
- Adequate organ function as defined by blood counts, chemistry, and coagulation parameters.
- Expected survival of at least 12 months.
- Voluntary written informed consent provided before screening.
You will not qualify if you...
- Current or history of other malignancies unless cured without recurrence in the past 5 years.
- Central nervous system involvement or transformation to high-grade lymphoma.
- Uncontrolled or significant cardiovascular diseases including heart failure, recent myocardial infarction, arrhythmia, cardiomyopathy, prolonged QTc, symptomatic coronary artery disease, or poorly controlled hypertension.
- Active bleeding within 2 months, current anticoagulant use, or bleeding tendency.
- History of 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.
- Severe lung conditions impairing pulmonary function.
- Prior treatment with BTK inhibitors or related pathway inhibitors.
- Pregnancy, lactation, or unwillingness to use contraception if applicable.
- Use of certain CYP3A inhibitors or inducers.
- Any 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.
Duration - Up to 12 cycles of 21 days each (approximately 9 months)
Participants receive cycles of orelabrutinib combined with rituximab, with treatment adapted based on response after 6 cycles.
Up to 12 treatment cycles with assessments at the end of each cycle
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
L
Lei Fan, PhD, MD
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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