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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005180-24 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib + rituximab | Active Comparator | Participants will receive idelalisib plus rituximab |
|
| Placebo + rituximab | Placebo Comparator | Participants will receive placebo to match idelalisib plus rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Idelalisib 150 mg tablet administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 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. | Up to 17 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | 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. |
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Inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Jahn, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Arizona Oncology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33297794 | Derived | 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. | |
| 32599655 |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
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Participants were enrolled at a total of 53 study sites in the United States and Europe. The first participant was screened on 03 April 2012. The last study visit occurred on 20 April 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idelalisib + Rituximab | Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter) |
| FG001 | Placebo + Rituximab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rituximab | Drug | Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter |
|
|
| Placebo to match idelalisib | Drug | Placebo to match idelalisib administered orally twice daily |
|
| Up to 17 months |
| Lymph Node Response Rate | 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. | Up to 17 months |
| Overall Survival | Overall survival was defined as the interval from randomization to death from any cause. | Up to 17 months |
| Complete Response Rate | Complete response rate was defined as the percentage of participants who achieved a complete response. | Up to 17 months |
| Tucson |
| Arizona |
| 85704 |
| United States |
| University of California, San Diego- Moores Cancer Center | La Jolla | California | 92093 | United States |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| UCLA | Santa Monica | California | 90404 | United States |
| Stanford Cancer Center | Stanford | California | 94305 | United States |
| Rocky Mountain Blood and Marrow Transplant Program | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20057 | United States |
| Collaborative Medical Research Corporation | Boynton Beach | Florida | 33435 | United States |
| Collaborative Research Group LLC | Boynton Beach | Florida | 33435 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Winship Cancer Institute at Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Hematology Oncology Associates of Northern New Jersey | Morristown | New Jersey | 07962 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11042 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Willamette Valley Cancer Center | Springfield | Oregon | 97477 | United States |
| Northwest Cancer Specialists, PC | Tualatin | Oregon | 97062 | United States |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| Texas Oncology, P.A. | Fort Worth | Texas | 76104 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Cancer Care Network of South Texas | San Antonio | Texas | 78217 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc | Roanoke | Virginia | 24014 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1024 | United States |
| Yakima Valley Memorial Hospital / North Star Lodge | Yakima | Washington | 98902 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| Centre Hospitalier Régional Universitaire de Lille (CHRU) | Lille | 59045 | France |
| Hôpital Emile Muller | Mulhouse | 68100 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Hôpital Pontchaillou | Rennes | 35019 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Hopital Purpan | Toulouse | 31059 | France |
| Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Gemeinschaftspraxis Hämatologie-Onkologie | Dresden | 1307 | Germany |
| Internistische Gemeinschaftspraxis | Erlangen | 91052 | Germany |
| Stauferklinikum Schwäb. Gmünd | Mutlangen | 73557 | Germany |
| Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth | Neunkirchen | 66538 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Ospedale Oncologico Regionale A. Businco | Cagliari | 9121 | Italy |
| Ospedale San Raffaele S.r.l. | Milan | 20132 | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Castle Hill Hospital | Cottingham | HU10 6ED | United Kingdom |
| Dorset County Hospital | Dorchester | DT1 2JY | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Northwick Park Hospital | Harrow | HA1 3UJ | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Hammersmith Hospital | London | W12 0NN | United Kingdom |
| Sarah Cannon Research Institute UK | London | W1G 6AD | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Princess Royal University Hospital | Orpington | BR6 8ND | United Kingdom |
| Salisbury District Hospital | Salisbury | SP2 8BJ | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Great Western Hospital | Swindon | SN3 6BB | United Kingdom |
| Torbay District General Hospital | Torquay | TQ2 7AA | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| Yeovil District Hospital | Yeovil | BA21 4AT | United Kingdom |
| 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. |
| 24450857 | Derived | 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. |
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Idelalisib + Rituximab | Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter) |
| BG001 | Placebo + Rituximab | Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Karnofsky Performance Status | Classifies patients according to their functional impairment. Scores range from 0-100; the lower the score, the worse the survival for most serious illnesses. | Number | participants |
| |||||||||||||||
| Time Since Diagnosis | Mean | Standard Deviation | months |
| |||||||||||||||
| Rai Stage at Screening | Rai staging categorizes the disease progression of chronic lymphocytic leukemia (CLL), with classifications of low- (Stage 0), intermediate- (Stage 1 and 2), and high-risk (Stages 3 and 4) categories. Rai Stage 0: high number of lymphocytes in the blood (lymphocytosis) only. Rai Stage 1: lymphocytosis with enlarged lymphoid tissues (lymphadenopathy). Rai Stage 2: lymphocytosis with enlarged liver (hepatomegaly) or spleen (splenomegaly). Rai Stage 3: lymphocytosis with low red blood cell count (anemia). Rai Stage 4: lymphocytosis with low number of blood platelets (thrombocytopenia). | Number | participants |
| |||||||||||||||
| Binet Stage at Screening | Binet staging classifies CLL according to the number of lymphoid tissues involved, as well as the presence of anemia or thrombocytopenia. Stage A: fewer than three areas of enlarged lymphoid tissue; enlarged lymph nodes of the neck, underarms, and groin, as well as the spleen, are each considered "one group" whether unilateral (one-sided) or bilateral (on both sides). Binet Stage B: more than three areas of enlarged lymphoid tissue. Binet Stage C: anemia plus thrombocytopenia. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival | 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. | Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization. | Posted | Median | 95% Confidence Interval | months | Up to 17 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | 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. | ITT Analysis Set: randomized participants with treatment group designated according to initial randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 17 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lymph Node Response Rate | 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. | ITT Analysis Set: randomized participants with treatment group designated according to initial randomization | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 17 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the interval from randomization to death from any cause. | ITT Analysis Set: randomized participants with treatment group designated according to initial randomization. | Posted | Median | 95% Confidence Interval | months | Up to 17 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate | Complete response rate was defined as the percentage of participants who achieved a complete response. | ITT Analysis Set: randomized participants with treatment group designated according to initial randomization. | Posted | Number | percentage of participants | Up to 17 months |
|
|
During study treatment plus 30 days (up to 2 years)
Safety Analysis Set: randomized participants who received at least 1 dose of study drug, with treatment assignments designated according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Idelalisib + Rituximab | Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter) | 65 | 110 | 103 | 110 | ||
| EG001 | Placebo + Rituximab | Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter) | 43 | 108 | 102 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastric mucosa erythema | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Alpha haemolytic streptococcal infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Fungal oesophagitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Stenotrophomonas infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Iiird nerve disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
Following a recommendation by an independent Data Monitoring Committee (DMC), the study was stopped early due to highly statistically significant results for the primary efficacy endpoint of progression-free survival.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C552946 | idelalisib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Not Permitted |
|
| Black or African American |
|
| Other |
|
| Not Permitted |
|
| Germany |
|
| Italy |
|
| United Kingdom |
|
| United States |
|
| 50 |
|
| 60 |
|
| 70 |
|
| 80 |
|
| 90 |
|
| 100 |
|
| Rai Stage 1 |
|
| Rai Stage 2 |
|
| Rai Stage 3 |
|
| Rai Stage 4 |
|
| Missing |
|
| Binet Stage B |
|
| Binet Stage C |
|
| Missing |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|