Actively Recruiting
A Prospective Study to Evaluate the Efficacy and Safety of MZL-IPI Risk-adapted Targeted Therapy in Patients With Untreated Marginal Zone B-cell Lymphoma
Led by Ruijin Hospital · Updated on 2026-03-24
145
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Marginal zone lymphoma (MZL) is a common slow-growing lymphoma that arises from the marginal zone of lymphoid follicles. Researchers are evaluating targeted therapies tailored to the risk level of MZL-IPI in newly diagnosed patients who need systemic treatment. This study aims to establish a precision treatment approach based on prognostic risk stratification for untreated MZL cases. Participants receive treatment based on their risk group: low-risk patients (MZL-IPI 0-2 points) receive the Obinutuzumab and Orelabrutinib (O2) regimen, while high-risk patients (MZL-IPI 3-5 points) receive the Obinutuzumab, Orelabrutinib, and Lenalidomide (O2R) regimen. Induction therapy includes Obinutuzumab given on specific days across 6 cycles, Orelabrutinib taken daily, and Lenalidomide for high-risk patients. After induction, maintenance treatment consists of daily Orelabrutinib monotherapy for up to 24 months. Throughout the study, participants will be monitored for 2-year progression-free survival, response rates at 6 cycles, 12 months, and 24 months, and treatment-related side effects. Assessments include evaluating response duration, histological transformation, and overall survival over approximately 24 months. Participants must comply with study procedures and will have regular evaluations of bone marrow, liver, and kidney function as well as performance status during the trial.
CONDITIONS
Brief Title
MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed CD20-positive marginal zone lymphoma as per 2016 WHO classification.
- Age 18 years or older, any gender.
- MZL patients requiring systemic treatment, including those with progression or relapse after local treatment or untreated patients meeting specific clinical criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy of at least 3 months.
- Adequate bone marrow (except due to MZL), liver, and kidney function.
- Ability to comply with research procedures and complete the study.
- Written informed consent given.
- Women of childbearing potential agree to use pregnancy prevention during treatment and for at least one year after; men agree to abstinence or barrier contraception.
You will not qualify if you...
- Histological transformation into high-grade lymphoma.
- Known involvement of central nervous system by MZL.
- Previous systemic treatment including immunotherapy, chemotherapy, or targeted drugs.
- Previous autologous or allogeneic stem-cell or organ transplantation.
- History of other invasive cancers within past 3 years not cured or still receiving treatment.
- Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infections.
- Known HIV infection or active hepatitis B or C virus infection (with certain exceptions).
- Recent live attenuated vaccination within 4 weeks before treatment; live vaccines prohibited during study.
- Ongoing treatment with strong/moderate CYP3A inhibitors or inducers.
- Inability to swallow capsules or significant gastrointestinal diseases.
- Psychiatric or other conditions impeding study compliance.
- Pregnant or breastfeeding women.
- Other uncontrolled medical conditions affecting study participation as judged by investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive induction therapy with Obinutuzumab and Orelabrutinib, with or without Lenalidomide, administered in 6 cycles of 21 days each.
Multiple visits corresponding to 6 treatment cycles
Duration - Up to 24 months
Participants receive Orelabrutinib monotherapy once daily for up to 24 months following induction therapy.
Regular visits during maintenance period
Trial Site Locations
Total: 3 locations
1
Shanghai Ruijin Hospital
Shanghai, China, China, 200025
Actively Recruiting
2
Affiliated First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
3
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
W
Weili Zhao
P
Pengpeng Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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