Trials / Terminated
TerminatedNCT01232556
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 338 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inotuzumab ozogamicin | 1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles |
| DRUG | Rituximab | 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles |
| DRUG | rituximab + gemcitabine | rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles |
| DRUG | rituximab +bendamustine | rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles |
Timeline
- Start date
- 2011-04-04
- Primary completion
- 2014-03-28
- Completion
- 2014-03-28
- First posted
- 2010-11-02
- Last updated
- 2019-01-08
- Results posted
- 2018-08-21
Locations
177 sites across 25 countries: United States, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Japan, Lithuania, Mexico, Poland, Puerto Rico, Russia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01232556. Inclusion in this directory is not an endorsement.