Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial

Sponsor
Fei Li
Study ID
NCT06700798
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
    150mg po
  • rituximab — DRUG
    375mg/m\^2, intravenous
  • Cyclophosphamide — DRUG
    750mg/m\^2
  • Vincristine — DRUG
    1.4mg/m\^2
  • Prednisone tablet — DRUG
    60mg/m\^2

Study Details

This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL

Key Dates

Start date
Dec 1, 2024
Status verified
Jun 2025
Primary completion
May 4, 2026
Completion
Dec 4, 2027

Study Design

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

Arms

  • Experimental: OR-R
    Orelabrutinib 150mg, oral, once daily, Days 1-28, with a cycle of 4 weeks; Cycles 1-24； Rituximab: 375mg/m\^2, intravenous, Day 1, with a cycle of 4 weeks; Cycles 1-6
  • Active Comparator: R-CVP
    Rituximab: 375mg/m\^2, intravenous, Day 1, with a cycle of 3 weeks; Cycles 1-8； Cyclophosphamide: 750mg/m\^2, intravenous, Day 1, with a cycle of 3 weeks;Cycles 1-8； Vincristine: 1.4mg/m\^2 (maximum 2mg), intravenous, Day 1, with a cycle of 3 weeks;Cycles 1-8； Prednisone: 60mg/m\^2, oral, Days 1-5, with a cycle of 3 weeks，Cycles 1-8 Subsequently, maintenance with rituximab monotherapy until two years from the start of treatment or until toxicity intolerable.

Primary Outcome Measure

CRR [ Time Frame: up to two years ]

Central Contacts