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NCT01659021 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 261
- Enrollment target
NCT01659021: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT01659021 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 261 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659021, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 261 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).
Primary Outcome
Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph no
Interventions
- DRUG Idelalisib
- DRUG Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2012-12-04 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 3 |
Why NCT01659021 stopped before completion
NCT01659021 is an interventional study that assigns participants to a tested intervention. The registered 261 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 (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Idelalisib is the first listed.
NCT01659021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01659021 about?
NCT01659021 is a clinical study titled "Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia". The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).
What is the current status of trial NCT01659021?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2012-12-04. Estimated completion is 2018-08-15.
What interventions are being tested in trial NCT01659021?
The interventions under investigation include: Idelalisib (DRUG), Ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01659021?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01659021's enrollment target sits among peer trials
261 1228th of 2000 higher than 771 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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