Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07441993
Phase
PHASE2
Status
Recruiting
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Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib — DRUG
    Induction phase (cycle 1-6): Orelabrutinib (150 mg)

Study Details

This is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.

Key Dates

First listed
Mar 2, 2026
Start date
Jan 5, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Marginal zone lymphoma: orelabrutinib

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days) ]

Central Contacts

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