The Efficacy and Safety of ZR2 Versus R-miniCHOP in the Treatment of Unfit or Frail de Novo Diffuse Large B-cell Lymphoma Patients Aged Older Than or Equal to 70 Years

Sponsor
Ruijin Hospital
Study ID
NCT05179733
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of zanubrutinib, rituximab and lenalidomide (ZR2) versus rituximab combined with low-dose CHOP (R-miniCHOP) in the treatment of unfit or frail de novo diffuse large B-cell lymphoma patients aged older than or equal to 70 years

Key Dates

Start date
Mar 2, 2022
Status verified
May 2023
Primary completion
Dec 25, 2025
Completion
Dec 25, 2025

Study Design

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

Arms

  • Experimental: ZR2
    six courses of zanubrutinib, rituximab and lenalidomide
  • Active Comparator: R-miniCHOP
    six courses of rituximab combined with low-dose CHOP

Primary Outcome Measure

Progression free survival [ Time Frame: Baseline up to data cut-off (up to approximately 2 years) ]

Central Contacts

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