Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT06478472
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 in combination with rituximab — DRUG
    Induction Phase: Orelabrutinib + rituximab for a total of 6 cycles of 28 days each Obrutinib (O) 150mg oral d1-28 Rituximab (R) 375mg/m2 IV d0 Maintenance phase: Orelabrutinib 150mg po qd 24 cycles of 28 days each

Study Details

Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma

Key Dates

Start date
Jun 23, 2024
Status verified
Jul 2024
Primary completion
Jun 23, 2027
Completion
Jun 23, 2027

Study Design

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

Arms

  • Experimental: OR
    Orelabrutinib in combination with rituximab

Primary Outcome Measure

CR [ Time Frame: Up to 36 months ]

Central Contacts

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