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NCT01732913 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 295
- Enrollment target
NCT01732913 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 295 participants.
The verdict
NCT01732913, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 295 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Interventions
- DRUG Placebo
- DRUG Rituximab
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2013-01-16 |
| Est. Completion | 2016-05-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01732913
The ClinicalTrials.gov registry entry for NCT01732913 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 295 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 Placebo is the first listed.
NCT01732913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01732913 about?
NCT01732913 is a clinical study titled "Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas". The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with f...
What is the current status of trial NCT01732913?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 295 participants. The study started on 2013-01-16. Estimated completion is 2016-05-18.
What interventions are being tested in trial NCT01732913?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Idelalisib (DRUG).
Who is sponsoring clinical trial NCT01732913?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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