MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL
NCT06793189 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2026-03-24
Summary
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
- Marginal Zone Lymphoma(MZL)
Interventions
- DRUG
-
Obinutuzumab and Orelabrutinib
Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days) and Orelabrutinib (150 mg once daily).
- DRUG
-
Obinutuzumab, Orelabrutinib and Lenalidomide
Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days), Orelabrutinib (150 mg once daily), and Lenalidomide (25 mg on days 2-11 of cycles 1-6, cycle length=21 days).
- DRUG
-
Orelabrutinib
Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).
- DRUG
-
Orelabrutinib
Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-23
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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