Trial intelligence / Profile preview

Pola-ZR2 vs ZR2 in Elderly DLBCL

NCT06522555Phase 3

Key facts

Status: Recruiting
Start: Jul 2024
Primary completion: Aug 2028
Countries: 1
Sponsor: Ruijin Hospital
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)

Drugs: polatuzumab vedotin
Conditions: diffuse large B-cell lymphoma (DLBCL)

Overview

Phase 3, randomised, open-label trial of polatuzumab vedotin in diffuse large B-cell lymphoma (DLBCL) (2 arms), sponsored by Ruijin Hospital. Primary endpoint: 2-year Progression-Free Survival Rate. Started Jul 2024; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Pola-ZR2
Polatuzumab vedotin + Zanubrutinib + Rituximab + Lenalidomide Induction -> Lenalidomide Maintenance
ZR2
Zanubrutinib + Rituximab + Lenalidomide Induction -> Lenalidomide Maintenance

Who it enrols

Elderly patients (>=80 or 70-79 unfit/frail) with de novo DLBCL, IPI 2-5, and measurable disease.

Endpoints

Primary

2-year Progression-Free Survival Rate2 years

Secondary

Progression-Free Survivalup to 2y
2-year Overall Survival Rate2 years
Overall Survivalup to 2y
Complete Response Rate6-8 weeks after last dose
Overall Response Rate6-8 weeks after last dose
Treatment-Related Adverse Eventsup to 5y
Improvement in EORTC QLQ-C3030 days post-treatment
Improvement in EORTC QLQ-ELD1430 days post-treatment

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