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 13, 2016
Last verified: April 2016
  Purpose
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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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: 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.


Secondary Outcome Measures:
  • 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 4 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.


Enrollment: 261
Study Start Date: December 2012
Estimated Study Completion Date: March 2017
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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®
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

Drug: Ofatumumab
Ofatumumab administered intravenously
Other Name: Arzerra®

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659021

  Show 84 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Ronald Dubowy, MD Gilead Sciences
  More Information

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 13, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Denmark: Danish Health and Medicines Authority
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Health Products Regulatory Authority
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016