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NCT01232556 · ClinicalTrials.gov registry record · Phase 3
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 338
- Enrollment target
NCT01232556: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT01232556 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 338 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01232556, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 338 participants
- Enrollment target
Study 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.
Primary Outcome
Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Interventions
- DRUG Rituximab
- DRUG Inotuzumab ozogamicin
- DRUG rituximab + gemcitabine
- DRUG rituximab +bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2011-04-04 |
| Est. Completion | 2014-03-28 |
| Phase | Phase 3 |
Why NCT01232556 stopped before completion
NCT01232556 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 4 interventions - of which Rituximab is the first listed.
NCT01232556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01232556 about?
NCT01232556 is a clinical study titled "A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy". 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 comp...
What is the current status of trial NCT01232556?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 338 participants. The study started on 2011-04-04. Estimated completion is 2014-03-28.
What interventions are being tested in trial NCT01232556?
The interventions under investigation include: Rituximab (DRUG), Inotuzumab ozogamicin (DRUG), rituximab + gemcitabine (DRUG), rituximab +bendamustine (DRUG).
Who is sponsoring clinical trial NCT01232556?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01232556's enrollment target sits among peer trials
338 1057th of 2000 higher than 942 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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