Overview

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

Status:
Terminated
Trial end date:
2014-03-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborator:
UCB Pharma
Treatments:
Bendamustine Hydrochloride
Gemcitabine
Inotuzumab Ozogamicin
Rituximab
Criteria
Inclusion Criteria:

-

Exclusion Criteria:

-