Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 57 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01980875
The ClinicalTrials.gov registry entry for NCT01980875 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT01980875 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.