A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

Summary

A study to evaluate the Efficacy and Safety of Polatuzumab Vedotin in combination with BR (Bendamustine and Rituximab) compared with BR alone in Chinese participants with R/R DLBCL. Approximately 42 Chinese participants will be randomised to treatment arms in a 2:1 ratio. Randomisation will be conducted with the aid of an interactive web-based response system (IxRS).

Timeline

Start

2020-07-10

Primary completion

2021-07-12

Completion

2022-02-07

Outcome

Missed primary endpoint

Stopped: “Sponsor's decision, no safety concerns”

registry Difference in Response Rates 10.71 (95% CI -19.00 to 40.43) NCT04236141 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Polatuzumab Vedotin	Other / unclassified	1.8 mg/kg	Intravenous
Background	Bendamustine	Small molecule	90 mg/m2	Intravenous
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Indications