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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06468943
Other study ID # Pola-ZR-CHP
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date July 1, 2023
Est. completion date May 1, 2028

Study information

Verified date April 2024
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. The POLARIX study also observed an benefit in the efficacy of Polatuzumab Vedotin in first-line treatment of DLBCL patients. 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Nanjing

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory study endpoint Exploring the therapeutic response of subjects with different genotypes to Pola+ZR-CHP regimen using Next-generation sequencing(NGS). 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.
Primary Progression-free Survival(PFS) The time between enrollment and tumor occurrence (in any aspect) progression or (for any reason) death 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.
Secondary Objective Response rate(ORR) The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of treatment 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.
Secondary Complete Response(CR) The proportion of patients who achieved complete response in efficacy evaluation at the end of treatment 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.
Secondary Duration of Response(DOR) It refers to the time from the first assessment of a tumor as CR or PR to the second assessment as PD (Progressive Disease) or death from any cause. All time in the study
Secondary Overall Survival The time between enrollment to death(for any reason) . 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.
Secondary Adverse Events(AEs) All treatment-related adverse events that occur during patient treatment and follow-up. 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.
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