Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma

Sponsor
Huai'an First People's Hospital
Study ID
NCT06566807
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, obinutuzumab — DRUG
    orelabrutinib，150mg，D1-D28 obinutuzumab，1000mg，D1、D8、D15/cycle1 D1/cycle2-6 . The patients will be treated with 6 cycles of O2 regimen. Patients with CR/PR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen.

Study Details

This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.

Key Dates

First listed
Aug 22, 2024
Start date
Aug 25, 2024
Status verified
Aug 2024
Primary completion
Aug 10, 2026
Completion
Aug 10, 2028

Study Design

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

Arms

  • Experimental: O2

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: At the end of Cycle 6 (each cycle is 28 days) ]

Central Contacts

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