Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06468943
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Effects of Chemotherapy
  • Safety Issues

Eligibility Criteria

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

Interventions

  • Polatuzumab Vedotin — DRUG
    1.8mg/kg/21d（d0） Intravenous infusion
  • Zanubrutinib — DRUG
    160mg bid PO（d0-d20）
  • Rituximab — DRUG
    375mg/㎡/21d（d0） Intravenous infusion
  • Cyclophosphamide — DRUG
    750mg/㎡/21d（d1） Intravenous infusion
  • Doxorubicin — DRUG
    50mg/㎡/21d（d1） Intravenous infusion
  • Prednisone — DRUG
    100mg PO （d1-d5）/21d

Study Details

Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Key Dates

Start date
Jul 1, 2023
Status verified
Apr 2024
Primary completion
May 1, 2026
Completion
May 1, 2028

Study Design

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

Arms

  • Experimental: Patients receiving Pola+ZR-CHP treatment

Primary Outcome Measure

Progression-free Survival（PFS） [ Time Frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause. ]

Related Studies