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NCT01569295 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 416
- Enrollment target
NCT01569295: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01569295 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 416 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01569295, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 416 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
Primary Outcome
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
Interventions
- DRUG Rituximab
- DRUG Bendamustine
- DRUG Idelalisib
- DRUG Placebo to match idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2012-06-15 |
| Est. Completion | 2019-06-10 |
| Phase | Phase 3 |
What the finished NCT01569295 record still lists
NCT01569295 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 4 interventions - of which Rituximab is the first listed.
NCT01569295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01569295 about?
NCT01569295 is a clinical study titled "Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )". The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
What is the current status of trial NCT01569295?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2012-06-15. Estimated completion is 2019-06-10.
What interventions are being tested in trial NCT01569295?
The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG), Idelalisib (DRUG), Placebo to match idelalisib (DRUG).
Who is sponsoring clinical trial NCT01569295?
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 NCT01569295's enrollment target sits among peer trials
416 902nd of 2000 higher than 1,098 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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