Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Study ID
NCT06082102
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed/Refractory Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Orelabrutinib — DRUG
    Orelabrutinib Tablets
  • Rituximab — DRUG
    Rituximab Injection
  • Lenalidomide — DRUG
    Lenalidomide Capsules
  • Rituximab — DRUG
    Rituximab Injection

Study Details

Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma

Key Dates

Start date
Dec 19, 2023
Status verified
Sep 2025
Primary completion
Aug 31, 2028
Completion
Feb 25, 2030

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Orelabrutinib
  • Active Comparator: Comparator

Primary Outcome Measure

IRC-assessed PFS [ Time Frame: Through study completion, an average of 5 year. ]

Central Contacts