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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: rituximab + gemcitabine; Drug: rituximab +bendamustine; Drug: Inotuzumab ozogamicin; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232556

2010-020147-12 (EudraCT Number)

B1931008

3129K5-3303 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 2 patient groups

1

Experimental group

Description:

Inotuzumab ozogamicin+rituximab

Treatment:

Drug: Inotuzumab ozogamicin

Drug: Rituximab

2

Active Comparator group

Description:

Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine

Treatment:

Drug: rituximab + gemcitabine

Drug: rituximab +bendamustine