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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003313-17 | EudraCT Number |
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The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib+bendamustine+rituximab | Experimental | Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. |
|
| Placebo+bendamustine+rituximab | Placebo Comparator | Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | 150 mg tablet administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC). | Up to 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC. | Up to 22 months |
| Nodal Response Rate |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center | Fullerton | California | 92835 | United States | ||
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.
392 participants were screened.
Participants were enrolled at study sites in the North America, Australia, and Europe. The first participant was screened on 05 February 2014. The last study visit occurred on 16 June 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idelalisib+Bendamustine+Rituximab | Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) |
| FG001 | Placebo+Bendamustine+Rituximab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Bendamustine | Drug | Administered intravenously at a starting dose of 90 mg/m^2 for up to 6 cycles. Dosing will be based on mg/m^2 of body surface area. |
|
| Rituximab | Drug | Single-use vials administered intravenously weekly starting at 375 mg/m^2 on Day 1 (Week 0) and 500 mg/m^2 thereafter for a total of 6 infusions |
|
| Placebo | Drug | Placebo to match idelalisib administered orally twice daily |
|
Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
| Up to 22 months |
| Complete Response Rate | Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC. | Up to 22 months |
| Overall Survival | Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC. | Up to 22 months |
| Minimal Residual Disease Negativity Rate at Week 36 | Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC. | Up to 22 months |
| UCSD Moores Cancer Center |
| La Jolla |
| California |
| 92093 |
| United States |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | United States |
| Florida Cancer Specialists-South | Sarasota | Florida | 34236 | United States |
| Franciscan Physician Network Oncology & Hematology | Indianapolis | Indiana | 46237 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89074 | United States |
| Hematology /Oncology Associates of Northern New Jersey | Morristown | New Jersey | 07962 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Sarah Cannon Research Institute | Cincinnati | Ohio | 45242 | United States |
| Signal Point Clinical Research Center | Middletown | Ohio | 45042 | United States |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84103 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| St Vincent's Hospital, Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Jarrett Street Specialist Centre | North Gosford | New South Wales | 2250 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre, Department of Haematology, Level 6 | Bedford Park | South Australia | 5042 | Australia |
| Ashford Cancer Centre Research | Kurralta Park | South Australia | 5037 | Australia |
| Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| Barwon Health, University Hospital Geelong | Geelong | Victoria | 3220 | Australia |
| Z N A Stuivenberg | Antwerp | 2060 | Belgium |
| AZ Sint-Jan AV Brugge-Oostende | Bruges | 8000 | Belgium |
| University Hospital Leuven | Leuven | 3000 | Belgium |
| Cancercare Manitoba - Maccharles Unit | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2C9 | Canada |
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| CHU de Québec - Hôpital de l'Enfant-Jésus | Québec | Quebec | G1J 1Z4 | Canada |
| Klinicka bolnica Dubrava | Zagreb | 10000 | Croatia |
| Klinicka bolnica Merkur | Zagreb | 10000 | Croatia |
| UHC Zagreb | Zagreb | 10000 | Croatia |
| Faculty hospital Ostrava | Ostrava-Poruba | Moravian-Silesian | 70852 | Czechia |
| University Hospital | Brno | 62500 | Czechia |
| Faculty Hospital Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Faculty Hospital Plzen | Pilsen | 304 60 | Czechia |
| Faculty Hospital Kralovske Vinohrady | Prague | 10034 | Czechia |
| CHRU de Lille, Hopital Claude Huriez | Lille | 59037 | France |
| Hospital Saint-Louis | Paris | 75010 | France |
| CHU Bretonneau | Tours | 37044 | France |
| Szent Borbála Hospital | Tatabánya | Komárom-Esztergom | 2800 | Hungary |
| Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar, | Kaposvár | Somogy County | 7400 | Hungary |
| Semmelweis University | Budapest | 1083 | Hungary |
| National Institute of Oncology | Budapest | 1122 | Hungary |
| University of Debrecen HSC Institute of internal Medicine, Department of Hematology | Debrecen | 4032 | Hungary |
| Pandy Kalman Hospital | Gyula | 5700 | Hungary |
| University Of Pecs, Medical School | Pécs | 7624 | Hungary |
| Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika | Szeged | 6725 | Hungary |
| IRCCS Istituto Tumori | Bari | Apulia | 70024 | Italy |
| Ospedale Oncologico Armando Businco | Cagliari | 09121 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliero Universitaria Policlinico di Modena | Modena | 41124 | Italy |
| AOU Maggiore della Carità | Novara | 28100 | Italy |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Malopolskie Centrum Medyczne s.c. | Krakow | 30-510 | Poland |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii | Lodz | 93-510 | Poland |
| Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii | Warsaw | 02-507 | Poland |
| Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego | Warsaw | 02-781 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku | Wroclaw | 50-367 | Poland |
| Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku | Wroclaw | 53-439 | Poland |
| Emergency County Clinical Hospital Brasov | Brasov | 500326 | Romania |
| Spitalul Clinic Colentina | Bucharest | 20125 | Romania |
| Hospital Vall de Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinic | Barcelona | Catalonia | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8041 | Spain |
| ICO, Hospitalet de Llobregat | Barcelona | 8908 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario Ramón Y Cajal | Madrid | 28033 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Puerta De Hierro | Madrid | 28222 | Spain |
| University College London | London | England | WC1E 6BT | United Kingdom |
| East Kent Hospitals University NHS Foundation Trust | Canterbury | Kent | CT1 3NG | United Kingdom |
| Royal Marsden NHS Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust | Liverpool | L7 8XP | United Kingdom |
| Hammersmith Hospitals NHS Trust | London | W12 0HS | United Kingdom |
| Oxford University Hospitals | Oxford | OX37LE | United Kingdom |
| University Hospital Southampton NHS Trust | Southampton | SO16 6YD | United Kingdom |
| Royal Wolverhampton Hospital NHS Trust, New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Analysis Set: who were randomized regardless of whether subjects received any study drug(s), or received a different regimen from the regimen to which they were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Idelalisib+Bendamustine+Rituximab | Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) |
| BG001 | Placebo+Bendamustine+Rituximab | Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Rai Stage at Screening | Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL) with higher stages reflecting increasing severity. Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis with lymphadenopathy, Rai Stage II: Lymphocytosis with hepatomegaly or splenomegaly, Rai Stage III: Lymphocytosis with anemia, Rai Stage IV: Lymphocytosis with thrombocytopenia. | Count of Participants | Participants |
| |||||||||||||||
| IgHV Mutation | The mutation status of the unique immunoglobulin gene (IgHV) rearrangement in the monoclonal proliferation of B-cells in CLL can be used to predict aggressiveness of the disease. Participants with a mutated IgHV gene usually have a less aggressive and more indolent disease, with longer overall survival. Participants with an unmutated IgHV gene usually have a more aggressive disease and shorter overall survival. | Count of Participants | Participants |
| |||||||||||||||
| 17p Deletion in CLL Cells | Participants with CLL who have a 17p deletion lack a portion of the chromosome that acts to suppress cancer growth and is a recognized negative prognostic risk factor. | Count of Participants | 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 (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC). | Intent to Treat (ITT) analysis set: all participants who are randomized in the study with treatment group designated according to initial randomization. Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments. | Posted | Median | 95% Confidence Interval | months | Up to 22 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC. | The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant. | Posted | Up to 22 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Nodal Response Rate | Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC. | The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant. | Posted | Up to 22 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate | Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC. | The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant. | Posted | Up to 22 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC. | The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant. | Posted | Up to 22 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease Negativity Rate at Week 36 | Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC. | The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant. | Posted | Up to 22 months |
|
|
Up to 22 months plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study treatment, 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+Bendamustine+Rituximab | Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) | 113 | 156 | 154 | 156 | ||
| EG001 | Placebo+Bendamustine+Rituximab | Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) | 68 | 154 | 150 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cytomegalovirus gastritis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Myocarditis infectious | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Strongyloidiasis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Diabetic amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Procedural pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Aortitis | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
|
The study was terminated in agreement with the FDA due to urgent safety measures. Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments.
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 | 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 |
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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
| Male |
|
| Black or African American |
|
| White |
|
| Other |
|
| Not Permitted |
|
| Not Hispanic or Latino |
|
| Not Permitted |
|
| Hungary |
|
| United States |
|
| United Kingdom |
|
| Spain |
|
| Canada |
|
| Czech Republic |
|
| Belgium |
|
| Poland |
|
| Italy |
|
| Australia |
|
| France |
|
| Croatia |
|
| Stage II |
|
| Stage III |
|
| Stage IV |
|
| Unmutated |
|
| Missing |
|
| Present |
|
| Missing |
|
| Participants |
|