A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT01539512
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + rituximab Rituximab Participants will receive placebo to match idelalisib plus rituximab Placebo + rituximab Placebo to match idelalisib Participants will receive placebo to match idelalisib plus rituximab Idelalisib + rituximab Idelalisib Participants will receive idelalisib plus rituximab Idelalisib + rituximab Rituximab Participants will receive idelalisib plus rituximab
- Primary Outcome Measures
Name Time Method Progression-Free Survival Up to 17 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
Name Time Method Overall Response Rate Up to 17 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 Up to 17 months Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
Overall Survival Up to 17 months Overall survival was defined as the interval from randomization to death from any cause.
Complete Response Rate Up to 17 months Complete response rate was defined as the percentage of participants who achieved a complete response.
Trial Locations
- Locations (71)
Winship Cancer Institute at Emory University
🇺🇸Atlanta, Georgia, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
UCLA
🇺🇸Santa Monica, California, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Ventura County Hematology Oncology Specialists
🇺🇸Oxnard, California, United States
Florida Cancer Specialists
🇺🇸Saint Petersburg, Florida, United States
Centre Hospitalier Régional Universitaire de Lille (CHRU)
🇫🇷Lille, France
University of California, San Diego- Moores Cancer Center
🇺🇸La Jolla, California, United States
Collaborative Research Group LLC
🇺🇸Boynton Beach, Florida, United States
Collaborative Medical Research Corporation
🇺🇸Boynton Beach, Florida, United States
Dorset County Hospital
🇬🇧Dorchester, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Willamette Valley Cancer Center
🇺🇸Springfield, Oregon, United States
Northwest Cancer Specialists, PC
🇺🇸Tualatin, Oregon, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
🇺🇸Roanoke, Virginia, United States
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Hôpital Emile Muller
🇫🇷Mulhouse, France
Hôpital Pontchaillou
🇫🇷Rennes, France
Hôpital Henri Mondor
🇫🇷Creteil, France
Centre Henri Becquerel
🇫🇷Rouen, France
Gemeinschaftspraxis Hämatologie-Onkologie
🇩🇪Dresden, Germany
Hopital Purpan
🇫🇷Toulouse, France
Internistische Gemeinschaftspraxis
🇩🇪Erlangen, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Stauferklinikum Schwäb. Gmünd
🇩🇪Mutlangen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Ospedale San Raffaele S.r.l.
🇮🇹Milano, Italy
Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth
🇩🇪Neunkirchen, Germany
Ospedale Oncologico Regionale A. Businco
🇮🇹Cagliari, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Princess Royal University Hospital
🇬🇧Orpington, United Kingdom
Sarah Cannon Research Institute UK
🇬🇧London, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Great Western Hospital
🇬🇧Swindon, United Kingdom
Torbay District General Hospital
🇬🇧Torquay, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
Georgetown University Medical Center Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Hematology Oncology Associates of Northern New Jersey
🇺🇸Morristown, New Jersey, United States
Texas Oncology, P.A.
🇺🇸Fort Worth, Texas, United States
Yakima Valley Memorial Hospital / North Star Lodge
🇺🇸Yakima, Washington, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Rocky Mountain Blood and Marrow Transplant Program
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Cancer Care Network of South Texas
🇺🇸San Antonio, Texas, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Castle Hill Hospital
🇬🇧Cottingham, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom