Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07448324
Phase
PHASE2
Status
Recruiting
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Conditions

  • Marginal Zone Lymphoma(MZL)

Eligibility Criteria

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

Interventions

  • Orelabrutinib — DRUG
    Orelabrutinib: 150mg qd C1-C6
  • Rituximab — DRUG
    Rituximab: C1-C6
  • Lenalidomide — DRUG
    After 6 cycles of orelabrutinib + rituximab CR: Continue orelabrutinib + rituximab for 6 cycles. PR/SD: Switch to orelabrutinib + rituximab + lenalidomide for 6 cycles. PD: Discontinue study treatment.

Study Details

This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).

Key Dates

Start date
Apr 1, 2025
Status verified
Apr 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2030

Study Design

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

Arms

  • Experimental: Orelabrutinib Combined with Rituximab ± Lenalidomide

Primary Outcome Measure

Complete response rate (CRR) [ Time Frame: At the end of cycle 12 (each cycle is 21 days) ]

Central Contacts