Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inotuzumab ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| rituximab +bendamustine | Drug | — | UNRESOLVED |
| rituximab + gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Inotuzumab ozogamicin+rituximab
- interventionNames
- Drug: Inotuzumab ozogamicin
- Drug: Rituximab
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
- interventionNames
- Drug: rituximab + gemcitabine
- Drug: rituximab +bendamustine
Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Exclusion Criteria: \-
References
Publications (0)
Data not yet available