RecruitingPhase 2NCT07608978

Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

35 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Summary

This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes. After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT/PET-CT during treatment and after completion of induction. Patients who achieve CR/PR/SD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR/PR/SD) during induction will discontinue the study. Patients with CR/PR/SD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance. Efficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression/relapse.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called POLA-R-CHP+Zanubrutinib for people with diffuse large b-cell lymphoma (dlbcl). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPOLA-R-CHP+Zanubrutinib

Previously untreated DLBCL patients harboring MCD/BN2/N1 subtypes were treated with Pola-ZRCHP (Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone，6 cycles, 21-day cycles), with Rituximab administered for 8 cycles. The regimen consisted of Polatuzumab vedotin (1.8 mg/kg IV, D1), Zanubrutinib (160 mg PO BID), and standard CHP (C 750 mg/m², H 50 mg/m² IV D1; P 100 mg PO D1-5). Following induction, patients achieving ≥Stable Disease (SD) per PET-CT entered the maintenance phase with Zanubrutinib (160 mg PO BID) and Tislelizumab (200 mg IV Q3W, up to 1 year), continuing until progression or unacceptable toxicity. Non-responders (\<SD) discontinued.