RecruitingPhase 2NCT06554600

A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma

The Efficiency and Safety of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Prospective, Single-arm, Multicenter Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

36 participants

Start Date

Aug 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multicenter, single-arm, open phase II study to explore the efficacy and safety of Zanubrutinib in combination with Polatuzumab Vedotin, bendamustine, and rituximab (Polo-ZBR) in subjects with relapsed/refractory diffuse large B-cell lymphoma. Subjects with relapsed/refractory DLBCL who met the inclusion/exclusion criteria were screened and treated with 4 courses of Pola-ZBR regimen after signing informed consent. Subjects achieving PR or CR were consolidated with autologous transplantation consolidation or the original regimen for 2 additional courses, and then given Zanubrutinib maintenance therapy for 1 year. The final follow-up was observed until 2 years after enrollment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing zanubrutinib (a BTK inhibitor pill) in combination with an infusion regimen of polatuzumab vedotin, bendamustine, and rituximab (called pola-BR) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) — an aggressive blood cancer that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are 18–75 years old with confirmed DLBCL that has returned or not responded after initial treatment - You have at least one measurable lymphoma lesion - You are in reasonable health (ECOG 0-2) with estimated survival of at least 3 months - You have adequate blood counts, liver, and kidney function **You may NOT be eligible if...** - Your lymphoma has spread to the brain (CNS involvement) - You have previously received an organ transplant or stem cell transplant - You have another active cancer, HIV, or active hepatitis B or C - You have significant bleeding problems or are on warfarin-type blood thinners - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGZanubrutinib

160mg bid PO(d0-d20)

DRUGPolatuzumab Vedotin

Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 1.8mg/kg Polatuzumab Vedotin on Day 2 of each cycle.

DRUGBendamustine

Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 70 mg/m2 Bendamustine on Days 2 and 3 of each cycle.

DRUGRituximab

Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 375 mg/m2 Rituximab on Day 1 of each cycle.


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, China

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NCT06554600