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

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ClinicalTrials.gov Identifier: NCT01569295
Recruitment Status : Active, not recruiting
First Posted : April 3, 2012
Results First Posted : February 27, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE April 3, 2012
Results First Submitted Date  ICMJE December 18, 2017
Results First Posted Date  ICMJE February 27, 2018
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE June 26, 2012
Actual Primary Completion Date October 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
Progression-Free Survival [ Time Frame: Up to 45 months ]
Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2012)
Progression-Free Survival [ Time Frame: 18 Months ]
Change History Complete list of historical versions of study NCT01569295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Overall Response Rate (ORR) [ Time Frame: Up to 45 months ]
    ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy. PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.
  • Lymph Node Response Rate [ Time Frame: Up to 45 months ]
    Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
  • Overall Survival [ Time Frame: Up to 47 months ]
    Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
  • Complete Response Rate [ Time Frame: Up to 40 months ]
    Complete response (CR) rate was defined as the percentage of participants who achieved a CR.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2012)
  • Overall Response Rate [ Time Frame: 18 months ]
  • Patient Well-Being (health-related quality-of-life questionnaire) [ Time Frame: 18 months ]
  • Disease-Related Biomarkers [ Time Frame: 18 months ]
  • Pharmacokinetics [ Time Frame: 6 months ]
    Peak Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin)
  • Incidence of Adverse Events [ Time Frame: 18 months ]
  • Health Resource Utilization (utility measure questionnaire) [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Official Title  ICMJE 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
Brief Summary The primary objective of this study is to evaluate the effect of the addition of idelalisib (IDL [GS-1101, Zydelig®]) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Idelalisib
    Idelalisib 150 mg administered orally twice daily
    Other Names:
    • GS-1101
    • CAL 101
    • CAL-101
    • Zydelig®
  • Drug: Rituximab
    Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
    Other Names:
    • Rituxan®
    • MabThera
  • Drug: Bendamustine
    Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
    Other Names:
    • Ribomustin
    • Treanda®
  • Drug: Placebo to match idelalisib
    Placebo to match idelalisib administered orally twice daily
Study Arms  ICMJE
  • Experimental: Idelalisib+bendamustine+rituximab
    Participants will receive idelalisib plus bendamustine and rituximab
    Interventions:
    • Drug: Idelalisib
    • Drug: Rituximab
    • Drug: Bendamustine
  • Placebo Comparator: Placebo to match idelalisib+bendamustine+rituximab
    Participants will receive placebo to match idelalisib plus bendamustine and rituximab
    Interventions:
    • Drug: Rituximab
    • Drug: Bendamustine
    • Drug: Placebo to match idelalisib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
416
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2012)
390
Estimated Study Completion Date  ICMJE May 2019
Actual Primary Completion Date October 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Recent history of a major non-CLL malignancy
  • Evidence of an ongoing infection
  • CLL refractory to bendamustine
  • Concurrent participation in another therapeutic clinical trial

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Croatia,   Czechia,   France,   Greece,   Hungary,   Ireland,   Italy,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries Argentina,   Czech Republic,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT01569295
Other Study ID Numbers  ICMJE GS-US-312-0115
2011-006292-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date May 2019

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