Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Timeline

Start

2010-08-26

Primary completion

2018-01-03

Completion

2018-12-26

Outcome

Missed primary endpoint

Stopped: “The study was terminated early as it did not meet the Primary efficacy objective after primary analysis.”

paper The study did not meet its primary end-point. PMID 33973233 ↗

registry analysis (superiority test); Ofa + Benda (Arm A) vs Benda (Arm B); p = 0.1390 NCT01077518 ↗

Publications

• Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bendamustine	Small molecule	90 mg/m2	—
Comparator	Bendamustine	Small molecule	120 mg/m2	—
Subject	Ofatumumab	Monoclonal antibody	1000 mg	—

Indications