Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01539291 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
NCT01539291: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT01539291 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 161 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01539291, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
Study Summary
The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.
Primary Outcome
PFS was defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria other than lymphocytosis alone. PFS was analyzed using Kaplan-Meier (KM) estimates.
Interventions
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2012-10-03 |
| Est. Completion | 2018-06-29 |
| Phase | Phase 3 |
Why NCT01539291 stopped before completion
NCT01539291 is an interventional study that assigns participants to a tested intervention. The registered 161 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 (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Idelalisib is the first listed.
NCT01539291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01539291 about?
NCT01539291 is a clinical study titled "Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)". The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study...
What is the current status of trial NCT01539291?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2012-10-03. Estimated completion is 2018-06-29.
What interventions are being tested in trial NCT01539291?
The interventions under investigation include: Idelalisib (DRUG).
Who is sponsoring clinical trial NCT01539291?
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 NCT01539291's enrollment target sits among peer trials
161 1478th of 2000 higher than 522 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06391034 · 161 participants · Phase 2
Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
- NCT06546670 · 161 participants · Phase 1
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
- NCT06616766 · 161 participants · Phase 1
A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
- NCT06752356 · 161 participants · Phase 3
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI