Clinical trial NCT01539512: A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
CAL-101
GS 1101
PI3K
GS-US-312-0117
idelalisib
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 220
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: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.


Eligibility criteria: Inclusion:

* 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
* Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: Up to 17 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 17 months
measure: Lymph Node Response Rate
timeFrame: Up to 17 months
measure: Overall Survival
timeFrame: Up to 17 months
measure: Complete Response Rate
timeFrame: Up to 17 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego- Moores Cancer Center
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Blood and Marrow Transplant Program
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center Lombardi Cancer Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Collaborative Medical Research Corporation
state: Florida
city: Boynton Beach
country: United States
facility: Collaborative Research Group LLC
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute at Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology Oncology Associates of Northern New Jersey
state: New Jersey
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Springfield
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Network of South Texas
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital / North Star Lodge
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille (CHRU)
city: Mulhouse
country: France
facility: Hôpital Emile Muller
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: Hopital Purpan
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie-Onkologie
city: Erlangen
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwäb. Gmünd
city: Neunkirchen
country: Germany
facility: Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Cagliari
country: Italy
facility: Ospedale Oncologico Regionale A. Businco
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l.
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Orpington
country: United Kingdom
facility: Princess Royal University Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
city: Torquay
country: United Kingdom
facility: Torbay District General Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
Study officials:
affiliation: Gilead Sciences
name: Thomas Jahn, MD
role: STUDY_DIRECTOR
References:
citation: Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.
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.
citation: Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.