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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.
Information provided by (Responsible Party):
Gilead Sciences Identifier:
First received: August 3, 2012
Last updated: February 14, 2017
Last verified: February 2017
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
Intervention Model: Parallel Assignment
Masking: None (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 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.

Secondary Outcome Measures:
  • 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).

Enrollment: 261
Actual Study Start Date: December 4, 2012
Estimated Study Completion Date: March 2023
Primary Completion Date: January 15, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

Drug: Ofatumumab
Ofatumumab administered intravenously
Other Name: Arzerra®


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  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 identifier: NCT01659021

  Hide Study Locations
United States, California
City of Hope
Duarte, California, United States, 91010
California Cancer Associates for Research and Excellence (CCARE)
Fresno, California, United States, 93720
Kaiser Permanente
San Diego, California, United States, 92120
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Stanford University Medical Center
Stanford, California, United States, 94305
Kaiser Permanente Vallejo Medical Center
Vallejo, California, United States, 94589
United States, Colorado
Kaiser Permanente of Colorado
Denver, Colorado, United States, 80205
Saint Mary's Regional Cancer Center
Grand Junction, Colorado, United States, 81501
United States, Florida
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Kentucky
Montgomery Cancer Center
Mount Sterling, Kentucky, United States, 40353
United States, Maryland
Center for Cancer and Blood Disorders, PC
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110-1010
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
The Ohio State University Medical Center
Columbus, Ohio, United States, 43202
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Upstate Oncology Associates
Greenville, South Carolina, United States, 29601
United States, Tennessee
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States, 37404
Tenessee Oncology, PLLC
Nashville, Tennessee, United States, 37203-1781
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Australia, New South Wales
Saint George and Sutherland Hospitals
Kogarah, New South Wales, Australia, 2217
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Haematology and Oncology Clinics of Australia at Mater
Milton, Queensland, Australia, 4064
Australia, South Australia
Ashford Cancer Centre Research
Ashford, South Australia, Australia, 5035
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Frankston Hospital
Melbourne, Victoria, Australia, 3199
Queen Elizabeth Hospital
Woodville, Australia, 5011
Ziekenhuis Netwerk Antwerpen
Antwerpen, Belgium, 2060
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Universitaire Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 2T9
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)
Sudbury, Ontario, Canada, P3E 5J1
Canada, Quebec
Centre Hospitalier Universitaire de Montréal
Montréal, Quebec, Canada, H1T 2M4
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Canada, Saskatchewan
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada, S4T 1A5
Cancer Care Manitoba
Winnipeg, Canada, R3E 0V9
Aalborg Hospital
Aalborg, Denmark, 9100
Aarhus University Hospital
Århus, Denmark, 8000
Center Hospitalier Universitaire de Bordeaux
Pessac Cedex, Aquitaine, France, 33604
Hôpital Saint Louis
Paris Cedex 10, Ile-de-france, France, 75010
Centre Hospitalier de Perpignan
Perpignan, Languedoc-Roussillon, France, 66046
Centre Hospitalier Universitaire Nancy
Vandoeuvre, Limousin, Lorraine, France, 54511
Centre Hospitalier Universitaire Purpan
Toulouse Cedex, Midi-pyrenees, France, 31059
CHRU Clermont- Ferrand CHU Estaing
Auvergne, France, 63000
Centre Hospitalier Universitaire Hôpital Avicenne
Ile-de-france, France, 93009
University College Cork
Cork, Ireland
Saint James's Hospital
Dublin, Ireland, 8
Collegium Medicum Uniwersytetu Jagiellonskiego w K
Kraków, Malopolskie, Poland, 31-501
Wojewódzki Szpital Specjalistyczny im. Janusza Kor
Slupsk, Pomorskie, Poland, 76-200
Szpital Specjalistyczny w Brzozowie
Brzozow, Poland, 36-200
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
Lódz, Poland, 93-510
Centralny Szpital Kliniczny MSW
Warszawa, Poland, 02-507
Samodzielny Publiczny Szpital Kliniczny N1 Klinika
Wroclaw, Poland, 50-367
Hospital Clínic i Provincial
Barcelona, Spain, 08025
Hospital Vall d´Hebrón
Barcelona, Spain, 08035
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Puerta de Hierro Majadahonda
Madrid, Spain, 28222
Hospital Morales Meseguer
Murcia, Spain, 30008
Sunderby Sjukhus
Luleå, Sweden, 971 80
Karolinska University Hospital Solna
Stockholm, Sweden, 171 64
Karolinska University Hospital Huddinge
Stockholm, Sweden, 171 76
United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5ST
Darent Valley Hospital
Dartford, England, United Kingdom, DA2 8DA
Royal Surrey County Hospital NHS Trust
Guildford, England, United Kingdom, GU2 7XX
Haematology and Transplant Unit
Manchester, England, United Kingdom, M20 4BX
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Saint James's University Hospital
Leeds, United Kingdom, LS9 7TF
University College London
London, United Kingdom, NW1 2PG
University College London
London, United Kingdom, WC1E 6BT
Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Gilead Sciences
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences Identifier: NCT01659021     History of Changes
Other Study ID Numbers: GS-US-312-0119
2012-001236-65 ( EudraCT Number )
Study First Received: August 3, 2012
Results First Received: February 14, 2017
Last Updated: February 14, 2017

Keywords provided by Gilead Sciences:
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017