Actively Recruiting
MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL
Led by Ruijin Hospital · Updated on 2026-03-24
145
Participants Needed
3
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for precision treatment of MZL.
CONDITIONS
Official 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:
- Gastric MALT patients with progression or relapse after local treatment.
- Non-gastric MALT patients with stage I-II and progression/relapse after local treatment, or untreated stage III-IV meeting GELF criteria.
- Splenic marginal zone lymphoma patients with progression/relapse after local treatment or untreated with specific symptomatic or progressive criteria.
- Nodal marginal zone lymphoma patients with stage I-II and progression/relapse after local treatment, or untreated stage III-IV meeting GELF criteria.
- ECOG performance status score of 0 to 2.
- Expected survival of at least 3 months.
- Adequate bone marrow (except due to MZL), liver, and kidney function.
- Ability to comply with study procedures and provide informed consent.
- Women of childbearing potential agree to use contraception during treatment and for one year after.
- Men agree to abstain or use barrier contraception during the same period.
You will not qualify if you...
- Histological transformation to high-grade lymphoma.
- Known involvement of central nervous system by MZL.
- Prior systemic treatment including immunotherapy, chemotherapy, or targeted therapy.
- Previous autologous stem cell or allogeneic tissue/organ transplantation.
- History of invasive cancers within past 3 years without curative treatment or ongoing treatment.
- Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infections including active pulmonary tuberculosis.
- Known HIV infection or active hepatitis B or C infection by PCR; seropositive with low viral load allowed.
- Vaccination with live attenuated vaccines within 4 weeks before treatment; such vaccines prohibited during study.
- Need for continuous treatment with strong or moderate CYP3A inhibitors or inducers.
- Inability to swallow capsules or significant gastrointestinal disorders.
- Psychiatric or other conditions impairing compliance.
- Pregnant or breastfeeding women.
- Other uncontrolled medical conditions affecting study participation as judged by investigator.
AI-Screening
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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
CONTACT
P
Pengpeng Xu
CONTACT
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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