Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01980888 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 311
- Enrollment target
NCT01980888: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT01980888 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 311 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980888, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 311 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Primary Outcome
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Interventions
- DRUG Placebo
- DRUG Rituximab
- DRUG Bendamustine
- DRUG Idelalisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2014-02-05 |
| Est. Completion | 2016-06-16 |
| Phase | Phase 3 |
Why NCT01980888 stopped before completion
NCT01980888 is an interventional study that assigns participants to a tested intervention. The registered 311 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 (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01980888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01980888 about?
NCT01980888 is a clinical study titled "Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia". The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse...
What is the current status of trial NCT01980888?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 311 participants. The study started on 2014-02-05. Estimated completion is 2016-06-16.
What interventions are being tested in trial NCT01980888?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Bendamustine (DRUG), Idelalisib (DRUG).
Who is sponsoring clinical trial NCT01980888?
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 NCT01980888's enrollment target sits among peer trials
311 1106th of 2000 higher than 894 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
- NCT04984551 · 312 participants · Phase 2
Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia
- NCT04999904 · 312 participants · NA
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
- NCT05220332 · 312 participants · NA
Church-based Intervention to Improve Blood Pressure in African Americans
- NCT05434234 · 312 participants · Phase 1
A Study of YL201 in Patients With Advanced Solid Tumors
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