Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

Sponsor
Liaoning Cancer Hospital & Institute
Study ID
NCT05887726
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    Zanubrutinib 160mg bid p.o d0-d20(21-day cycles)
  • Rituximab — DRUG
    Rituximab 375 mg/m2 i.v d0(21-day cycles)
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750 mg/m2 i.v d1(21-day cycles)
  • Epirubicin — DRUG
    Epirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles)
  • Vincristine — DRUG
    Vincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles)
  • Prednisone — DRUG
    Prednisone 100 mg p.o d1-d5 (21-day cycles)

Study Details

This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.

Key Dates

Start date
Aug 1, 2023
Status verified
Feb 2023
Primary completion
Aug 1, 2024
Completion
Aug 1, 2025

Study Design

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

Arms

  • Experimental: Zanubrutinib + R-CHOP

Primary Outcome Measure

Complete response rate（CRR） [ Time Frame: Up to approximately 2.5 years ]

Central Contacts

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