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NCT01980875 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
NCT01980875: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT01980875 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 57 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980875, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Primary Outcome
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Interventions
- DRUG Obinutuzumab
- DRUG Idelalisib
- DRUG Chlorambucil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2015-04-21 |
| Est. Completion | 2016-05-13 |
| Phase | Phase 3 |
Why NCT01980875 stopped before completion
NCT01980875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT01980875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01980875 about?
NCT01980875 is a clinical study titled "Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia". The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and ser...
What is the current status of trial NCT01980875?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2015-04-21. Estimated completion is 2016-05-13.
What interventions are being tested in trial NCT01980875?
The interventions under investigation include: Obinutuzumab (DRUG), Idelalisib (DRUG), Chlorambucil (DRUG).
Who is sponsoring clinical trial NCT01980875?
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 NCT01980875's enrollment target sits among peer trials
57 1827th of 2000 higher than 174 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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