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Polatuzumab Vedotin + R-CHP or G-CHP in B-Cell NHL

NCT01992653Phase 2

Key facts

Status: Completed
Start: Nov 2013
Primary completion: Dec 2018
Countries: 2
Sponsor: Genentech
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)

Drugs: polatuzumab vedotin
Conditions: B-cell non-Hodgkin lymphomadiffuse large B-cell lymphoma (DLBCL)

Overview

Phase 2, open-label trial of polatuzumab vedotin in B-cell non-Hodgkin lymphoma and diffuse large B-cell lymphoma (DLBCL), sponsored by Genentech. Primary endpoints: Number of Participants With Adverse Events at 5 years and Number of Participants With Dose Limiting Toxicities at 3 weeks. Started Nov 2013; status: completed.

Design

Study design: Non-randomizedOpen-label

Who it enrols

Patients with B-cell NHL (DLBCL for expansion), ECOG 0-2, and adequate organ function. Excludes prior anthracyclines, significant neuropathy, and active infections.

Endpoints

Primary

Number of Participants With Adverse Events5 years
Number of Participants With Dose Limiting Toxicities3 weeks

Secondary

Percentage of Participants With Objective Response6 months
Number of Participants With Anti-Polatuzumab Vedotin Antibodies9 months
Pharmacokinetic Parameters of Polatuzumab Vedotin9 months
Peripheral Neuropathy Symptom Severity (TINAS)6 months
Duration of Response2.75 years
Progression Free Survival2.75 years
Event Free Survival2.75 years
Overall Survival6 years

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