A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

Summary

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

Timeline

Start

2011-04-04

Primary completion

2014-03-28

Completion

2014-03-28

Outcome

Missed primary endpoint

Stopped: “The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.”

registry p = 0.708; Hazard Ratio (HR) 1.083 (95% CI 0.82 to 1.44); Log Rank NCT01232556 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bendamustine	Small molecule	120 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Inotuzumab Ozogamicin	Monoclonal antibody	1.8 mg/m2	Intravenous
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Indications