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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 416 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01569295
The ClinicalTrials.gov registry entry for NCT01569295 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 416 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 4 interventions - of which Rituximab is the first listed.
NCT01569295 reports 0 study locations.
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.
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