Trial record 1 of 1 for:    NCT01659021
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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: April 14, 2014
Last verified: April 2014
  Purpose

This study is to 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).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Idelalisib
Drug: Ofatumumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Baseline to Month 18 ] [ 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.


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
    Overall response rate is defined as the proportion of participants who achieve a complete response or partial response.

  • Lymphadenopathy response rate [ Time Frame: Baseline to Month 18 ] [ 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 18 ] [ 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 18 ] [ Designated as safety issue: No ]
    Complete response (CR) rate is defined as the proportion of participants who achieve a CR.


Estimated Enrollment: 270
Study Start Date: December 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Idelalisib+ofatumumab
Participants will receive idelalisib plus ofatumumab for 24 weeks.
Drug: Idelalisib
Idelalisib 150 mg tablets administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
Drug: Ofatumumab
Ofatumumab administered intravenously weekly (300 mg on Day 1; thereafter 1000 mg for Part A and 2000 mg for Part B)
Other Name: Arzerra
Active Comparator: Arm B: Ofatumumab
Participants will receive ofatumumab for 24 weeks.
Drug: Ofatumumab
Ofatumumab administered intravenously weekly (300 mg on Day 1; thereafter 1000 mg for Part A and 2000 mg for Part B)
Other Name: Arzerra

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659021

  Show 86 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Ronald Dubowy, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01659021     History of Changes
Other Study ID Numbers: GS-US-312-0119, 2012-001236-65
Study First Received: August 3, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
CLL
Chronic Lymphocytic Leukemia
GS-1101
CAL-101
Ofatumumab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014