Clinical trial NCT01659021: Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
Chronic Lymphocytic Leukemia
GS-1101
CAL-101
Ofatumumab
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: Randomization to End of Study (up to 60 months)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Randomization to End of Study (up to 60 months)
measure: Lymph Node Response Rate
timeFrame: Randomization to End of Study (up to 60 months)
measure: Overall Survival
timeFrame: Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
measure: Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
timeFrame: Randomization to End of Study (up to 60 months)
measure: Complete Response Rate
timeFrame: Randomization to End of Study (up to 60 months)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence (CCARE)
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Vallejo Medical Center
state: California
city: Denver
country: United States
facility: Kaiser Permanente of Colorado
state: Colorado
city: Grand Junction
country: United States
facility: Saint Mary's Regional Cancer Center
state: Colorado
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders, PC
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Greenville
country: United States
facility: Upstate Oncology Associates
state: South Carolina
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tenessee Oncology, PLLC
state: Tennessee
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Kogarah
country: Australia
facility: Saint George and Sutherland Hospitals
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Milton
country: Australia
facility: Haematology and Oncology Clinics of Australia at Mater
state: Queensland
city: Ashford
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Frankston Hospital
state: Victoria
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Gasthuisberg
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Sudbury
country: Canada
facility: Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal
state: Quebec
city: Rimouski
country: Canada
facility: Centre Hospitalier Regional de Rimouski
state: Quebec
city: Regina
country: Canada
facility: Saskatchewan Cancer Agency
state: Saskatchewan
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Århus
country: Denmark
facility: Aarhus University Hospital
city: Pessac Cedex
country: France
facility: Center Hospitalier Universitaire de Bordeaux
state: Aquitaine
city: Paris Cedex 10
country: France
facility: Hôpital Saint Louis
state: Ile-de-france
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan
state: Languedoc-Roussillon
city: Vandoeuvre
country: France
facility: Centre Hospitalier Universitaire Nancy
state: Limousin, Lorraine
city: Toulouse Cedex
country: France
facility: Centre Hospitalier Universitaire Purpan
state: Midi-pyrenees
city: Auvergne
country: France
facility: CHRU Clermont- Ferrand CHU Estaing
city: Ile-de-france
country: France
facility: Centre Hospitalier Universitaire Hôpital Avicenne
city: Cork
country: Ireland
facility: University College Cork
city: Dublin
country: Ireland
facility: Saint James's Hospital
city: Kraków
country: Poland
facility: Collegium Medicum Uniwersytetu Jagiellonskiego w K
state: Malopolskie
city: Slupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Janusza Kor
state: Pomorskie
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie
city: Lódz
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny N1 Klinika
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebrón
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Luleå
country: Sweden
facility: Sunderby Sjukhus
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: England
city: Dartford
country: United Kingdom
facility: Darent Valley Hospital
state: England
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Trust
state: England
city: Manchester
country: United Kingdom
facility: Haematology and Transplant Unit
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Leeds
country: United Kingdom
facility: Saint James's University Hospital
city: London
country: United Kingdom
facility: University College London
city: London
country: United Kingdom
facility: University College London
city: Oxford
country: United Kingdom
facility: Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4.
citation: Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.
citation: Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.
citation: Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark.
citation: Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria.
citation: Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. 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 (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL.
citation: Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.