Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07208981
Phase
PHASE2
Status
Recruiting
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Conditions

  • Marginal Zone Lymphoma(MZL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib — DRUG
    Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Maintenance phase (a total of 24 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Patients who achieve complete remission (CR) or partial remission (PR) after 6 cycles will decide whether to undergo maintenance therapy based on the investigator's choice.
  • Zebetuzumab — DRUG
    Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Zebetuzumab (375 mg/m2, d1/C1-C6).
  • Lenalidomide — DRUG
    Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Lenalidomide (20 mg, d1-d21).
  • Bendamustine + Rituximab — DRUG
    Treatment period (a total of 6 cycles, each cycle lasting 28 days), Bendamustine (90 mg/m2, d1-2), Rituximab (375 mg/m2, d1/C1-6).

Study Details

This is an open-label, multicenter, phase 2, non-randomized study aiming to evaluate the efficacy and safety of orelabrutinib combined with zebetuzumab and lenalidomide or bendamustine combined with rituximab in the treatment of newly diagnosed marginal zone lymphoma (MZL).

Key Dates

Start date
Aug 14, 2025
Status verified
Aug 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2031

Study Design

Enrollment
169 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group of orelabrutinib combined with zebetuzumab and lenalidomide
  • Active Comparator: Group of bendamustine combined with rituximab

Primary Outcome Measure

3-year PFS rate [ Time Frame: From the first dose of treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months. ]

Central Contacts