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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: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT02044822 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
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 |
Why NCT02044822 stopped before completion
NCT02044822 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT02044822 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02044822's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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