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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
160mg bid PO(d0-d20)
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.
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.
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.
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China
RECRUITINGObjective Response rate(ORR)
The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of induction treatment.
Time frame: Up to 12 weeks
Complete Response rate(CRR)
The proportion of patients who achieved complete response in efficacy evaluation at the end of induction treatment.
Time frame: Up to 12 weeks
Progression-free Survival(PFS)
PFS was defined as the period from date of enrollment until the date of disease progression, relapse, or death from any cause.
Time frame: Up to 2 years after enrollment
Overall Survival(OS)
OS was defined as the time from date of randomization until the date of death from any cause.
Time frame: Up to 2 years after enrollment
Percentage of Participants With Adverse Events (AEs)
Toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Up to 12 weeks
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