A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Summary

The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.

Timeline

Start

2016-11-28

Primary completion

2024-06-21

Completion

2024-06-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Tafasitamab + Bendamustine vs Rituximab + Bendamustine; p = 0.468; Hazard Ratio (HR) 1.06 (95% CI 0.837 to 1.351); Inverse normal test NCT02763319 ↗

registry analysis (superiority test); Tafasitamab + Bendamustine vs Rituximab + Bendamustine; p = 0.568; Hazard Ratio (HR) 0.88 (95% CI 0.586 to 1.330); Inverse normal test NCT02763319 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Subject	Tafasitamab	Monoclonal antibody	12 mg/kg	Intravenous
Background	Bendamustine	Small molecule	—	—

Indications