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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: February 14, 2017
Last verified: February 2017

August 3, 2012
February 14, 2017
December 4, 2012
January 15, 2015   (Final data collection date for primary outcome measure)
Progression-Free Survival [ Time Frame: Up to 37 months ]
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
Progression-Free Survival [ Time Frame: 18 months ]
Complete list of historical versions of study NCT01659021 on ClinicalTrials.gov Archive Site
  • Overall Response Rate [ Time Frame: Up to 37 months ]

    Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

    • Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
    • Partial response 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.
  • Lymph Node Response Rate [ Time Frame: Up to 37 months ]
    Lymph node response rate was defined as the proportion of participants who achieved 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 5 years ]
    Overall survival was 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 37 months ]
  • Complete Response Rate [ Time Frame: Up to 37 months ]
    Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).
  • 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 ]
    Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)
  • Incidence of Adverse Events [ Time Frame: 18 months ]
  • Health Resource Utilization (utility measure questionnaire) [ Time Frame: 18 months ]
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
Intervention Model: Parallel Assignment
Masking: No masking
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 for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

    Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

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

    Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

    Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

    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 15, 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.

Sexes Eligible for Study: All
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 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
February 2017

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