Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01539512 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
A Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT01539512 is a Phase 3 study of Chronic Lymphocytic Leukemia that has completed, run by Gilead Sciences. The registered enrollment target is 220 participants, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT01539512, a Phase 3 study of Chronic Lymphocytic Leukemia, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Idelalisib
- DRUG Placebo to match idelalisib
Study Locations (20)
Florida
- Collaborative Medical Research Corporation - Boynton Beach
- Collaborative Research Group LLC - Boynton Beach
- Florida Cancer Specialists - Fort Myers
- University of Florida - Gainesville
- Florida Cancer Specialists - St. Petersburg
California
- University of California, San Diego- Moores Cancer Center - La Jolla
- Ventura County Hematology Oncology Specialists - Oxnard
- UCLA - Santa Monica
- Stanford Cancer Center - Stanford
Colorado
- Rocky Mountain Blood and Marrow Transplant Program - Denver
- Rocky Mountain Cancer Center - Denver
New Jersey
- Hackensack University Medical Center - Hackensack
- Hematology Oncology Associates of Northern New Jersey - Morristown
New York
- Long Island Jewish Medical Center - New Hyde Park
- Weill Cornell Medical College - New York
Alabama
- Clearview Cancer Institute - Huntsville
Arizona
- Arizona Oncology Associates - Tucson
District of Columbia
- Georgetown University Medical Center Lombardi Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01539512
The ClinicalTrials.gov registry entry for NCT01539512 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (22% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT01539512 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT01539512 about?
NCT01539512 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)". This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomize...
What is the current status of trial NCT01539512?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2012-04. Estimated completion is 2014-04.
What conditions does trial NCT01539512 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT01539512?
The interventions under investigation include: Rituximab (DRUG), Idelalisib (DRUG), Placebo to match idelalisib (DRUG).
Who is sponsoring clinical trial NCT01539512?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01539512 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Long-term Extension Study of PCI-32765 (Ibrutinib)
RECRUITING · Phase 3
-
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
RECRUITING · Phase 3
-
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
RECRUITING · Phase 3
-
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
RECRUITING · Phase 3
-
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
RECRUITING · Phase 3
-
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.