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NCT02044822 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT02044822 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 102 participants.
The verdict
NCT02044822, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. 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 Rituximab
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2014-08-06 |
| Est. Completion | 2016-05-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02044822
The ClinicalTrials.gov registry entry for NCT02044822 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 102 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 2 interventions - of which Rituximab is the first listed.
NCT02044822 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02044822 about?
NCT02044822 is a clinical study titled "Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion". The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among parti...
What is the current status of trial NCT02044822?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2014-08-06. Estimated completion is 2016-05-17.
What interventions are being tested in trial NCT02044822?
The interventions under investigation include: Rituximab (DRUG), Idelalisib (DRUG).
Who is sponsoring clinical trial NCT02044822?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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