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NCT01077518 · ClinicalTrials.gov registry record · Phase 3
Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 346
- Enrollment target
NCT01077518: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01077518 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 346 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01077518, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 346 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
Primary Outcome
PFS is defined as the time interval between randomization until disease progression or death (due to any cause).
Interventions
- DRUG Ofatumumab
- DRUG Bendamustine infusion
- DRUG Ofatumumab and Bendamustine infusions (Arm A)
- DRUG Bendamustine infusion (Arm B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2010-08-26 |
| Est. Completion | 2018-12-26 |
| Phase | Phase 3 |
Why NCT01077518 stopped before completion
NCT01077518 is an interventional study that assigns participants to a tested intervention. The registered 346 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 (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Ofatumumab is the first listed.
NCT01077518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01077518 about?
NCT01077518 is a clinical study titled "Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy". The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
What is the current status of trial NCT01077518?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2010-08-26. Estimated completion is 2018-12-26.
What interventions are being tested in trial NCT01077518?
The interventions under investigation include: Ofatumumab (DRUG), Bendamustine infusion (DRUG), Ofatumumab and Bendamustine infusions (Arm A) (DRUG), Bendamustine infusion (Arm B) (DRUG).
Who is sponsoring clinical trial NCT01077518?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01077518's enrollment target sits among peer trials
346 1049th of 2000 higher than 951 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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