RecruitingPhase 2NCT06664411

Pola-ZR2P in Previously Untreated DLBCL

Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma

Sponsor

Navy General Hospital, Beijing

Enrollment

80 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

Summary

The goal of this phase 2 trial is to test the safety and efficacy of Pola-ZR2P as induction therapy in patients with DLBCL.

Eligibility

Min Age: 14 Years

Inclusion Criteria6

Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
Patient has not received chemotherapy previously.
Anticipated life expectancy at least 3 months

Exclusion Criteria3

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
Pregnant or lactating women

Interventions

DRUGPolatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone as Induction Therapy

Patients were treated by Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po bid d1-21), Rituximab(375mg/m2 iv qd d1), Lenalidomide(25mg po qd d1-14) and Prednisone(60mg/m2 po qd d1-5) as induction therapy