Extension Study of Idelalisib for Patients With Chronic Lymphocytic Leukemia Who Participated in GS-US-312-0116

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539291
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : June 4, 2018
Information provided by (Responsible Party):
Gilead Sciences

February 12, 2012
February 27, 2012
June 4, 2018
October 3, 2012
May 21, 2018   (Final data collection date for primary outcome measure)
Overall Safety [ Time Frame: Baseline to Month 12 ]
Overall safety profile of each study treatment regimen will be characterized by the type, frequency, severity, timing of onset, duration, and relationship to study therapy of any adverse events or abnormalities of laboratory tests, serious adverse events, or adverse events leading to discontinuation of study drug.
Overall Response Rate [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01539291 on Archive Site
  • Tumor Control [ Time Frame: Baseline to Month 12 ]
    Tumor control will be assessed by progression-free survival, overall response rate, lymph node response rate, complete response rate, time to response, duration of response, percent change in lymph node area, splenomegaly response rate, hepatomegaly response rate, absolute lymphocyte count (ALC) response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate.
  • Patient Well-Being [ Time Frame: Baseline to Month 12 ]
    Patient well-being will be assessed by overall survival, change from baseline in health-related quality of life (HRQL) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Leukemia (FACT-Leu), and changes from baseline in Karnofsky performance status.
  • Pharmacodynamic [ Time Frame: Baseline to Month 6 ]
    Pharmacodynamics will be assessed by changes from baseline in phosphatidylinositol 3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathway activation and changes from baseline in the plasma concentrations of disease-associated chemokines and cytokines.
  • Patient Well-Being (Health related quality of life questionnaires) [ Time Frame: 12 months ]
  • Disease related biomarkers [ Time Frame: 12 months ]
  • Pharmacokinetic [ Time Frame: 6 months ]
    Pharmacokinetic to measure peak plasma concentrations (Cmax) as well as the area under the plasma concentration versus time curve (AUC).
  • Incidence of adverse events [ Time Frame: 12 months ]
  • Health Resource Utilization [ Time Frame: 12 months ]
Not Provided
Not Provided
Extension Study of Idelalisib for Patients With Chronic Lymphocytic Leukemia Who Participated in GS-US-312-0116
A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia
This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension study that is a companion study to Study GS-US-312-0116, to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
Drug: Idelalisib
Idelalisib 150 mg tablet(s) administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL 101
  • Active Comparator: High-dose Idelalisib
    Participants will receive idelalisib 300 mg twice daily (600 mg per day).
    Intervention: Drug: Idelalisib
  • Active Comparator: Standard-dose Idelalisib
    Participants will receive idelalisib 150 mg twice daily (300 mg per day)
    Intervention: Drug: Idelalisib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 21, 2018
May 21, 2018   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
  • Tolerating primary study therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   United Kingdom,   United States
2011-006293-72 ( EudraCT Number )
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP