Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06513234
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 and obinutuzumab — DRUG
    Orelabrutinib and obinutuzumab 6cycles ;orelabrutinib 150mg

Study Details

This is a prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab a in untreated marginal zone lymphoma. It is planned to recruit 45 patients. The primary endpoint is the complete remission rate at 12 months.

Key Dates

First listed
Jul 22, 2024
Start date
Jul 11, 2024
Status verified
Jun 2024
Primary completion
Jun 21, 2026
Completion
Jun 21, 2029

Study Design

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

Arms

  • Experimental: OG
    6 cycles of OG regimen. Patients with CR/PR after 6 cycles of OG treatment will be treated with 18 cycles of single-agent orelabrutinib regimen. Orelabrutinib 150mg QD

Primary Outcome Measure

the complete response rate [ Time Frame: At 12 months. ]

Central Contacts

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