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Efficacy and Safety of Idelalisib (GS-1101; CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01659021
First received: August 3, 2012
Last updated: October 27, 2016
Last verified: October 2016

August 3, 2012
October 27, 2016
December 2012
January 2015   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Up to 4 years ] [ 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 NCT01659021 on ClinicalTrials.gov Archive Site
  • Overall response rate [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Overall response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) and maintain their response for at least 8 weeks.
  • Lymphadenopathy response rate [ Time Frame: Up to 4 years ] [ 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: Up to 9 years ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as the interval from randomization to death from any cause.
  • Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Complete response rate [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Complete response rate is defined as the proportion of participants who achieve a CR and maintained their response for at least 8 weeks.
  • 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 ]
    Evaluation of plasma concentrations at peak (Cmax) and trough (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
 
Efficacy and Safety of Idelalisib (GS-1101; CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
This study will evaluate the effect of the addition of idelalisib (GS-1101) to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Drug: Idelalisib
    Idelalisib 150 mg tablets administered orally twice daily
    Other Names:
    • Zydelig®
    • GS-1101
    • CAL-101
  • Drug: Ofatumumab
    Ofatumumab administered intravenously
    Other Name: Arzerra®
  • Experimental: Idelalisib+ofatumumab

    Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab (300 mg on Day 1, followed by 1000 mg weekly for 8 weeks, and then 1000 mg every 4 weeks for 4 doses)

    Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until definitive progression of CLL or protocol-specified study withdrawal

    Interventions:
    • Drug: Idelalisib
    • Drug: Ofatumumab
  • Active Comparator: Ofatumumab

    Randomized Initial Therapy (24 weeks): Ofatumumab (300 mg on Day 1, followed by 2000 mg weekly for 8 weeks, and then 2000 mg every 4 weeks for 4 doses)

    Continuing Therapy/Observation: Observation until definitive progression of CLL or protocol-specified study withdrawal

    Intervention: Drug: Ofatumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
261
March 2023
January 2015   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Adults with previously treated recurrent CLL who have measurable lymphadenopathy
  • Require therapy for CLL
  • Have experienced CLL progression < 24 months since the completion of the last prior therapy
  • Have disease that is not refractory to ofatumumab

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

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Denmark,   France,   Ireland,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT01659021
GS-US-312-0119, 2012-001236-65
Yes
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
October 2016

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