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NCT01108341 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01108341: Completed Phase 2 study, sponsored by Cephalon.
NCT01108341 is a Phase 2 study that has completed, run by Cephalon. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01108341, a Phase 2 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).
Primary Outcome
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
Interventions
- DRUG Ofatumumab
- DRUG Bendamustine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT01108341 record still lists
NCT01108341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Ofatumumab is the first listed.
NCT01108341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01108341 about?
NCT01108341 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)". The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).
What is the current status of trial NCT01108341?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2010-05. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01108341?
The interventions under investigation include: Ofatumumab (DRUG), Bendamustine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01108341?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01108341's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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