Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT04835870
Phase
PHASE2
Status
Unknown

Conditions

  • Non-GCB/ABC Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    Zanubrutinib-160mg bid PO d0-d20(1-21d)
  • Rituximab — DRUG
    Rituximab-375 mg/m2 i.v d0 (/21d)
  • Cyclophosphamide — DRUG
    Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
  • Doxorubicin — DRUG
    Doxorubicin-50 mg/m2 i.v d1 (/21d)
  • Vincristine — DRUG
    Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
  • Prednisone — DRUG
    Prednisone-100 mg p.o d1-d5 (/21d)

Study Details

Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients

Key Dates

Start date
Apr 1, 2021
Status verified
Mar 2022
Primary completion
Oct 1, 2025
Completion
Oct 1, 2025

Study Design

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

Arms

  • Experimental: R-CHOP + Zanubrutinib
    Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Primary Outcome Measure

Progression-free Survival(PFS) [ Time Frame: up to 18 months ]

Central Contacts