A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01569295
First received: March 27, 2012
Last updated: July 24, 2014
Last verified: July 2014

March 27, 2012
July 24, 2014
June 2012
December 2016   (final data collection date for primary outcome measure)
Progression-Free Survival [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause.
Progression-Free Survival [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01569295 on ClinicalTrials.gov Archive Site
  • Overall Response Rate [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response.
  • Lymph Node Response Rate [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Lymph node response rate is defined as the proportion of participants who achieve a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.
  • Overall Survival [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as the interval from randomization to death from any cause.
  • Complete Response Rate [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Complete response (CR) rate is defined as the proportion of participants who achieve a CR.
  • Overall Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Patient Well-Being (health-related quality-of-life questionnaire) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Disease-Related Biomarkers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Peak Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin)
  • Incidence of Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Health Resource Utilization (utility measure questionnaire) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo. All subjects will be administered bendamustine and rituximab.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Drug: Idelalisib
    Idelalisib 150 mg administered orally twice daily
    Other Names:
    • GS-1101
    • CAL 101
    • CAL-101
  • Drug: Rituximab
    Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 administered intravenously thereafter
    Other Name: Rituxan, MabThera
  • Drug: Bendamustine
    Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously
    Other Name: Ribomustin, Treanda, SDX-105
  • Drug: Placebo
    Placebo to match idelalisib administered orally twice daily
  • Active Comparator: Idelalisib + bendamustine/rituximab
    Interventions:
    • Drug: Idelalisib
    • Drug: Rituximab
    • Drug: Bendamustine
  • Placebo Comparator: Placebo + bendamustine/rituximab
    Interventions:
    • Drug: Rituximab
    • Drug: Bendamustine
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
390
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion:

  • Previously treated recurrent CLL
  • Measurable lymphadenopathy
  • Requires therapy for CLL
  • Has experienced CLL progression <36 months since the completion of the last prior therapy

Exclusion:

  • Recent history of a major non-CLL malignancy
  • Evidence of an ongoing infection
  • CLL refractory to bendamustine
  • Concurrent participation in another therapeutic clinical trial
Both
18 Years and older
No
Contact: Maria Aiello, MA 206-256-4927 maria.aiello@gilead.com
United States,   Argentina,   Australia,   Belgium,   Canada,   Croatia,   Czech Republic,   France,   Greece,   Hungary,   Ireland,   Italy,   New Zealand,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Turkey,   United Kingdom
 
NCT01569295
GS-US-312-0115, 2011-006292-20
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Thomas Jahn, MD Gilead Sciences
Gilead Sciences
July 2014

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