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Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Bridalveil)

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ClinicalTrials.gov Identifier: NCT01732926
Recruitment Status : Terminated
First Posted : November 26, 2012
Results First Posted : May 11, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Indolent Non-Hodgkin's Lymphomas
Interventions Drug: Idelalisib
Drug: Rituximab
Drug: Bendamustine
Drug: Placebo
Enrollment 475
Recruitment Details Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 02 January 2013. The last study visit occurred on 17 May 2016.
Pre-assignment Details 581 participants were screened.
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Hide Arm/Group Description

Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions)

+ rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)

Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Period Title: Overall Study
Started 320 155
Completed [1] 53 45
Not Completed 267 110
Reason Not Completed
Study Terminated by Sponsor             168             80
Withdrawal by Subject             46             8
Physician Decision             24             11
Other Reason             21             4
Initiation of Other Anti-Cancer Therapy             7             6
Blind Broken by Subject or Study Site             1             1
[1]
Completed = reached primary efficacy endpoint of progressive disease or death
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab Total
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Total of all reporting groups
Overall Number of Baseline Participants 320 155 475
Hide Baseline Analysis Population Description
The Intent to Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 320 participants 155 participants 475 participants
62  (10.5) 62  (11.1) 62  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 155 participants 475 participants
Female
132
  41.3%
58
  37.4%
190
  40.0%
Male
188
  58.8%
97
  62.6%
285
  60.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 155 participants 475 participants
Asian
26
   8.1%
8
   5.2%
34
   7.2%
Black or African American
2
   0.6%
2
   1.3%
4
   0.8%
White
247
  77.2%
122
  78.7%
369
  77.7%
Other
4
   1.3%
2
   1.3%
6
   1.3%
Not Permitted
41
  12.8%
21
  13.5%
62
  13.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 155 participants 475 participants
Hispanic or Latino
16
   5.0%
8
   5.2%
24
   5.1%
Not Hispanic or Latino
262
  81.9%
129
  83.2%
391
  82.3%
Not Permitted
42
  13.1%
18
  11.6%
60
  12.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 155 participants 475 participants
Russian Federation
16
   5.0%
11
   7.1%
27
   5.7%
United States
37
  11.6%
12
   7.7%
49
  10.3%
United Kingdom
33
  10.3%
20
  12.9%
53
  11.2%
Spain
21
   6.6%
11
   7.1%
32
   6.7%
Canada
47
  14.7%
19
  12.3%
66
  13.9%
Czech Republic
12
   3.8%
7
   4.5%
19
   4.0%
Sweden
3
   0.9%
2
   1.3%
5
   1.1%
Taiwan
7
   2.2%
2
   1.3%
9
   1.9%
Poland
25
   7.8%
11
   7.1%
36
   7.6%
Korea, Republic of
10
   3.1%
2
   1.3%
12
   2.5%
Italy
21
   6.6%
14
   9.0%
35
   7.4%
Israel
6
   1.9%
2
   1.3%
8
   1.7%
France
36
  11.3%
18
  11.6%
54
  11.4%
Australia
44
  13.8%
23
  14.8%
67
  14.1%
Germany
2
   0.6%
1
   0.6%
3
   0.6%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Complete Response Rate (CR)
Hide Description Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Lymph Node Response Rate
Hide Description Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the interval from randomization to death from any cause.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 34 months plus 30 days
Adverse Event Reporting Description Safety Analysis Set: all participants who took at least 1 dose of study drug
 
Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
All-Cause Mortality
Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   229/317 (72.24%)   58/155 (37.42%) 
Blood and lymphatic system disorders     
Anaemia  1  8/317 (2.52%)  4/155 (2.58%) 
Aplasia pure red cell  1  1/317 (0.32%)  0/155 (0.00%) 
Autoimmune haemolytic anaemia  1  1/317 (0.32%)  0/155 (0.00%) 
Febrile bone marrow aplasia  1  1/317 (0.32%)  0/155 (0.00%) 
Febrile neutropenia  1  45/317 (14.20%)  7/155 (4.52%) 
Haemolytic anaemia  1  0/317 (0.00%)  1/155 (0.65%) 
Leukocytosis  1  1/317 (0.32%)  0/155 (0.00%) 
Leukopenia  1  1/317 (0.32%)  0/155 (0.00%) 
Neutropenia  1  8/317 (2.52%)  3/155 (1.94%) 
Pancytopenia  1  1/317 (0.32%)  0/155 (0.00%) 
Thrombocytopenia  1  4/317 (1.26%)  2/155 (1.29%) 
Cardiac disorders     
Acute myocardial infarction  1  1/317 (0.32%)  0/155 (0.00%) 
Angina unstable  1  1/317 (0.32%)  1/155 (0.65%) 
Arrhythmia supraventricular  1  1/317 (0.32%)  0/155 (0.00%) 
Atrial fibrillation  1  1/317 (0.32%)  1/155 (0.65%) 
Atrioventricular block complete  1  0/317 (0.00%)  1/155 (0.65%) 
Cardiac arrest  1  1/317 (0.32%)  0/155 (0.00%) 
Cardiac failure  1  1/317 (0.32%)  0/155 (0.00%) 
Cardiac failure acute  1  2/317 (0.63%)  0/155 (0.00%) 
Cardiac failure congestive  1  1/317 (0.32%)  0/155 (0.00%) 
Cardio-respiratory arrest  1  0/317 (0.00%)  1/155 (0.65%) 
Coronary artery stenosis  1  1/317 (0.32%)  0/155 (0.00%) 
Dilatation ventricular  1  1/317 (0.32%)  0/155 (0.00%) 
Myocardial infarction  1  1/317 (0.32%)  0/155 (0.00%) 
Right ventricular failure  1  1/317 (0.32%)  0/155 (0.00%) 
Tachyarrhythmia  1  1/317 (0.32%)  0/155 (0.00%) 
Ventricular arrhythmia  1  1/317 (0.32%)  0/155 (0.00%) 
Ear and labyrinth disorders     
Ear pain  1  1/317 (0.32%)  0/155 (0.00%) 
Vertigo  1  1/317 (0.32%)  0/155 (0.00%) 
Eye disorders     
Ophthalmoplegia  1  1/317 (0.32%)  0/155 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/317 (0.32%)  0/155 (0.00%) 
Abdominal pain  1  3/317 (0.95%)  0/155 (0.00%) 
Colitis  1  9/317 (2.84%)  0/155 (0.00%) 
Colitis ischaemic  1  1/317 (0.32%)  0/155 (0.00%) 
Diarrhoea  1  14/317 (4.42%)  2/155 (1.29%) 
Dyspepsia  1  1/317 (0.32%)  1/155 (0.65%) 
Dysphagia  1  1/317 (0.32%)  0/155 (0.00%) 
Faecaloma  1  0/317 (0.00%)  1/155 (0.65%) 
Gastric haemorrhage  1  1/317 (0.32%)  0/155 (0.00%) 
Gastrointestinal pain  1  1/317 (0.32%)  0/155 (0.00%) 
Gingival pain  1  1/317 (0.32%)  0/155 (0.00%) 
Haematochezia  1  1/317 (0.32%)  0/155 (0.00%) 
Incarcerated umbilical hernia  1  0/317 (0.00%)  1/155 (0.65%) 
Nausea  1  6/317 (1.89%)  1/155 (0.65%) 
Oesophageal ulcer haemorrhage  1  1/317 (0.32%)  0/155 (0.00%) 
Oesophagitis  1  2/317 (0.63%)  0/155 (0.00%) 
Pancreatitis  1  1/317 (0.32%)  0/155 (0.00%) 
Small intestinal obstruction  1  1/317 (0.32%)  0/155 (0.00%) 
Vomiting  1  8/317 (2.52%)  1/155 (0.65%) 
General disorders     
Asthenia  1  1/317 (0.32%)  0/155 (0.00%) 
Chest pain  1  2/317 (0.63%)  0/155 (0.00%) 
Chills  1  2/317 (0.63%)  0/155 (0.00%) 
Death  1  1/317 (0.32%)  0/155 (0.00%) 
Device related thrombosis  1  1/317 (0.32%)  0/155 (0.00%) 
Fatigue  1  1/317 (0.32%)  0/155 (0.00%) 
Hypothermia  1  0/317 (0.00%)  1/155 (0.65%) 
Mucosal inflammation  1  1/317 (0.32%)  2/155 (1.29%) 
Oedema  1  1/317 (0.32%)  0/155 (0.00%) 
Oedema peripheral  1  1/317 (0.32%)  0/155 (0.00%) 
Pain  1  1/317 (0.32%)  0/155 (0.00%) 
Pyrexia  1  67/317 (21.14%)  2/155 (1.29%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/317 (0.32%)  0/155 (0.00%) 
Cholelithiasis  1  2/317 (0.63%)  0/155 (0.00%) 
Cholestasis  1  1/317 (0.32%)  0/155 (0.00%) 
Hepatitis toxic  1  2/317 (0.63%)  0/155 (0.00%) 
Hepatocellular injury  1  2/317 (0.63%)  0/155 (0.00%) 
Hepatotoxicity  1  1/317 (0.32%)  0/155 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/317 (0.00%)  1/155 (0.65%) 
Drug hypersensitivity  1  3/317 (0.95%)  1/155 (0.65%) 
Hypersensitivity  1  4/317 (1.26%)  0/155 (0.00%) 
Infections and infestations     
Acute sinusitis  1  1/317 (0.32%)  0/155 (0.00%) 
Anal abscess  1  0/317 (0.00%)  1/155 (0.65%) 
Arthritis infective  1  1/317 (0.32%)  0/155 (0.00%) 
Aspergillus infection  1  1/317 (0.32%)  0/155 (0.00%) 
Atypical pneumonia  1  1/317 (0.32%)  1/155 (0.65%) 
Bacteraemia  1  1/317 (0.32%)  0/155 (0.00%) 
Bronchiolitis  1  0/317 (0.00%)  1/155 (0.65%) 
Bronchitis  1  2/317 (0.63%)  0/155 (0.00%) 
Campylobacter infection  1  1/317 (0.32%)  0/155 (0.00%) 
Candida infection  1  1/317 (0.32%)  0/155 (0.00%) 
Cellulitis  1  5/317 (1.58%)  1/155 (0.65%) 
Clostridium difficile colitis  1  3/317 (0.95%)  0/155 (0.00%) 
Clostridium difficile infection  1  1/317 (0.32%)  1/155 (0.65%) 
Conjunctivitis  1  2/317 (0.63%)  0/155 (0.00%) 
Cytomegalovirus colitis  1  1/317 (0.32%)  0/155 (0.00%) 
Cytomegalovirus hepatitis  1  1/317 (0.32%)  0/155 (0.00%) 
Cytomegalovirus infection  1  6/317 (1.89%)  0/155 (0.00%) 
Cytomegalovirus viraemia  1  1/317 (0.32%)  0/155 (0.00%) 
Dengue fever  1  0/317 (0.00%)  1/155 (0.65%) 
Device related infection  1  1/317 (0.32%)  0/155 (0.00%) 
Empyema  1  0/317 (0.00%)  1/155 (0.65%) 
Encephalitis  1  0/317 (0.00%)  1/155 (0.65%) 
Enteritis infectious  1  1/317 (0.32%)  0/155 (0.00%) 
Erysipelas  1  0/317 (0.00%)  1/155 (0.65%) 
Gastroenteritis  1  0/317 (0.00%)  1/155 (0.65%) 
Gastroenteritis norovirus  1  1/317 (0.32%)  0/155 (0.00%) 
Gastroenteritis viral  1  0/317 (0.00%)  2/155 (1.29%) 
Gingivitis  1  0/317 (0.00%)  1/155 (0.65%) 
Groin abscess  1  2/317 (0.63%)  0/155 (0.00%) 
Haematoma infection  1  1/317 (0.32%)  0/155 (0.00%) 
Herpes simplex  1  1/317 (0.32%)  0/155 (0.00%) 
Herpes zoster  1  2/317 (0.63%)  1/155 (0.65%) 
Infected skin ulcer  1  0/317 (0.00%)  1/155 (0.65%) 
Infection  1  1/317 (0.32%)  1/155 (0.65%) 
Infectious colitis  1  1/317 (0.32%)  0/155 (0.00%) 
Influenza  1  4/317 (1.26%)  1/155 (0.65%) 
Listeria sepsis  1  1/317 (0.32%)  0/155 (0.00%) 
Lower respiratory tract infection  1  5/317 (1.58%)  3/155 (1.94%) 
Lower respiratory tract infection fungal  1  1/317 (0.32%)  0/155 (0.00%) 
Lung infection  1  3/317 (0.95%)  0/155 (0.00%) 
Neutropenic sepsis  1  4/317 (1.26%)  2/155 (1.29%) 
Oesophageal candidiasis  1  1/317 (0.32%)  0/155 (0.00%) 
Oral candidiasis  1  1/317 (0.32%)  0/155 (0.00%) 
Otitis media chronic  1  1/317 (0.32%)  1/155 (0.65%) 
Pneumocystis jirovecii infection  1  1/317 (0.32%)  0/155 (0.00%) 
Pneumocystis jirovecii pneumonia  1  9/317 (2.84%)  0/155 (0.00%) 
Pneumonia  1  24/317 (7.57%)  4/155 (2.58%) 
Pneumonia bacterial  1  2/317 (0.63%)  0/155 (0.00%) 
Pneumonia chlamydial  1  1/317 (0.32%)  0/155 (0.00%) 
Pneumonia cytomegaloviral  1  1/317 (0.32%)  0/155 (0.00%) 
Pneumonia fungal  1  1/317 (0.32%)  0/155 (0.00%) 
Pseudomonal bacteraemia  1  1/317 (0.32%)  0/155 (0.00%) 
Pseudomonal sepsis  1  1/317 (0.32%)  0/155 (0.00%) 
Respiratory syncytial virus infection  1  1/317 (0.32%)  0/155 (0.00%) 
Respiratory tract infection  1  0/317 (0.00%)  2/155 (1.29%) 
Salmonellosis  1  1/317 (0.32%)  0/155 (0.00%) 
Sepsis  1  9/317 (2.84%)  1/155 (0.65%) 
Septic shock  1  2/317 (0.63%)  2/155 (1.29%) 
Sinusitis  1  3/317 (0.95%)  0/155 (0.00%) 
Staphylococcal sepsis  1  1/317 (0.32%)  0/155 (0.00%) 
Systemic mycosis  1  1/317 (0.32%)  0/155 (0.00%) 
Upper respiratory tract infection  1  4/317 (1.26%)  0/155 (0.00%) 
Urinary tract infection  1  6/317 (1.89%)  1/155 (0.65%) 
Urosepsis  1  2/317 (0.63%)  0/155 (0.00%) 
Varicella  1  3/317 (0.95%)  0/155 (0.00%) 
Varicella zoster virus infection  1  0/317 (0.00%)  1/155 (0.65%) 
Viral upper respiratory tract infection  1  1/317 (0.32%)  0/155 (0.00%) 
Injury, poisoning and procedural complications     
Craniocerebral injury  1  0/317 (0.00%)  1/155 (0.65%) 
Fall  1  1/317 (0.32%)  0/155 (0.00%) 
Femoral neck fracture  1  1/317 (0.32%)  0/155 (0.00%) 
Hip fracture  1  2/317 (0.63%)  0/155 (0.00%) 
Infusion related reaction  1  5/317 (1.58%)  3/155 (1.94%) 
Lower limb fracture  1  1/317 (0.32%)  0/155 (0.00%) 
Procedural pain  1  1/317 (0.32%)  0/155 (0.00%) 
Road traffic accident  1  0/317 (0.00%)  1/155 (0.65%) 
Sacroiliac fracture  1  1/317 (0.32%)  0/155 (0.00%) 
Splenic rupture  1  1/317 (0.32%)  0/155 (0.00%) 
Stoma site haemorrhage  1  1/317 (0.32%)  0/155 (0.00%) 
Wrist fracture  1  1/317 (0.32%)  0/155 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  14/317 (4.42%)  0/155 (0.00%) 
Aspartate aminotransferase increased  1  12/317 (3.79%)  0/155 (0.00%) 
Blood bilirubin increased  1  1/317 (0.32%)  0/155 (0.00%) 
Blood creatinine increased  1  1/317 (0.32%)  0/155 (0.00%) 
Blood lactate dehydrogenase increased  1  2/317 (0.63%)  0/155 (0.00%) 
Electrocardiogram QT prolonged  1  1/317 (0.32%)  0/155 (0.00%) 
Neutrophil count decreased  1  0/317 (0.00%)  3/155 (1.94%) 
Transaminases increased  1  2/317 (0.63%)  0/155 (0.00%) 
Weight decreased  1  1/317 (0.32%)  0/155 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/317 (0.32%)  0/155 (0.00%) 
Dehydration  1  6/317 (1.89%)  1/155 (0.65%) 
Hyperkalaemia  1  1/317 (0.32%)  0/155 (0.00%) 
Hyperuricaemia  1  1/317 (0.32%)  0/155 (0.00%) 
Hypokalaemia  1  1/317 (0.32%)  0/155 (0.00%) 
Hyponatraemia  1  1/317 (0.32%)  1/155 (0.65%) 
Tumour lysis syndrome  1  4/317 (1.26%)  0/155 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/317 (0.63%)  0/155 (0.00%) 
Back pain  1  1/317 (0.32%)  0/155 (0.00%) 
Intervertebral disc protrusion  1  1/317 (0.32%)  0/155 (0.00%) 
Joint swelling  1  1/317 (0.32%)  0/155 (0.00%) 
Muscular weakness  1  1/317 (0.32%)  0/155 (0.00%) 
Polyarthritis  1  1/317 (0.32%)  0/155 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal cancer  1  0/317 (0.00%)  1/155 (0.65%) 
B-cell lymphoma  1  0/317 (0.00%)  1/155 (0.65%) 
Breast cancer  1  0/317 (0.00%)  1/155 (0.65%) 
Clear cell renal cell carcinoma  1  1/317 (0.32%)  0/155 (0.00%) 
Endometrial adenocarcinoma  1  1/317 (0.32%)  0/155 (0.00%) 
Lung adenocarcinoma  1  2/317 (0.63%)  0/155 (0.00%) 
Malignant melanoma  1  1/317 (0.32%)  0/155 (0.00%) 
Myelodysplastic syndrome  1  2/317 (0.63%)  1/155 (0.65%) 
Oesophageal carcinoma  1  0/317 (0.00%)  1/155 (0.65%) 
Plasma cell myeloma  1  1/317 (0.32%)  0/155 (0.00%) 
Richter's syndrome  1  1/317 (0.32%)  0/155 (0.00%) 
Squamous cell carcinoma  1  1/317 (0.32%)  0/155 (0.00%) 
Nervous system disorders     
Balance disorder  1  1/317 (0.32%)  0/155 (0.00%) 
Central nervous system lesion  1  1/317 (0.32%)  0/155 (0.00%) 
Cerebrovascular accident  1  2/317 (0.63%)  0/155 (0.00%) 
Complex regional pain syndrome  1  1/317 (0.32%)  0/155 (0.00%) 
Embolic stroke  1  1/317 (0.32%)  0/155 (0.00%) 
Facial paralysis  1  1/317 (0.32%)  0/155 (0.00%) 
Lethargy  1  1/317 (0.32%)  0/155 (0.00%) 
Mixed dementia  1  1/317 (0.32%)  0/155 (0.00%) 
Presyncope  1  0/317 (0.00%)  1/155 (0.65%) 
Spinal cord compression  1  1/317 (0.32%)  0/155 (0.00%) 
Syncope  1  1/317 (0.32%)  0/155 (0.00%) 
Transient ischaemic attack  1  1/317 (0.32%)  0/155 (0.00%) 
VIth nerve paralysis  1  1/317 (0.32%)  0/155 (0.00%) 
Product Issues     
Device dislocation  1  1/317 (0.32%)  0/155 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/317 (0.32%)  1/155 (0.65%) 
Renal and urinary disorders     
Acute kidney injury  1  6/317 (1.89%)  2/155 (1.29%) 
Nephrotic syndrome  1  1/317 (0.32%)  0/155 (0.00%) 
Renal failure  1  3/317 (0.95%)  0/155 (0.00%) 
Renal impairment  1  1/317 (0.32%)  0/155 (0.00%) 
Urinary retention  1  1/317 (0.32%)  0/155 (0.00%) 
Reproductive system and breast disorders     
Prostatitis  1  0/317 (0.00%)  1/155 (0.65%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/317 (0.32%)  0/155 (0.00%) 
Acute respiratory failure  1  2/317 (0.63%)  0/155 (0.00%) 
Aspiration  1  1/317 (0.32%)  0/155 (0.00%) 
Asthma  1  1/317 (0.32%)  0/155 (0.00%) 
Atelectasis  1  1/317 (0.32%)  0/155 (0.00%) 
Bronchitis chronic  1  1/317 (0.32%)  0/155 (0.00%) 
Chronic obstructive pulmonary disease  1  1/317 (0.32%)  0/155 (0.00%) 
Dyspnoea  1  3/317 (0.95%)  0/155 (0.00%) 
Hydrothorax  1  1/317 (0.32%)  0/155 (0.00%) 
Hypoxia  1  2/317 (0.63%)  0/155 (0.00%) 
Lung disorder  1  2/317 (0.63%)  1/155 (0.65%) 
Lung infiltration  1  1/317 (0.32%)  0/155 (0.00%) 
Organising pneumonia  1  1/317 (0.32%)  0/155 (0.00%) 
Pleural effusion  1  5/317 (1.58%)  0/155 (0.00%) 
Pleurisy  1  0/317 (0.00%)  1/155 (0.65%) 
Pneumonia aspiration  1  1/317 (0.32%)  0/155 (0.00%) 
Pneumonitis  1  16/317 (5.05%)  0/155 (0.00%) 
Pulmonary embolism  1  3/317 (0.95%)  0/155 (0.00%) 
Pulmonary fibrosis  1  1/317 (0.32%)  0/155 (0.00%) 
Pulmonary hypertension  1  1/317 (0.32%)  0/155 (0.00%) 
Pulmonary mass  1  1/317 (0.32%)  0/155 (0.00%) 
Respiratory failure  1  6/317 (1.89%)  0/155 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  0/317 (0.00%)  1/155 (0.65%) 
Blister  1  1/317 (0.32%)  0/155 (0.00%) 
Dermatitis allergic  1  1/317 (0.32%)  0/155 (0.00%) 
Dermatitis exfoliative  1  2/317 (0.63%)  0/155 (0.00%) 
Ecchymosis  1  1/317 (0.32%)  0/155 (0.00%) 
Generalised erythema  1  1/317 (0.32%)  0/155 (0.00%) 
Pustular psoriasis  1  1/317 (0.32%)  0/155 (0.00%) 
Rash  1  18/317 (5.68%)  0/155 (0.00%) 
Rash generalised  1  3/317 (0.95%)  0/155 (0.00%) 
Rash maculo-papular  1  5/317 (1.58%)  0/155 (0.00%) 
Stevens-Johnson syndrome  1  1/317 (0.32%)  0/155 (0.00%) 
Toxic epidermal necrolysis  1  1/317 (0.32%)  0/155 (0.00%) 
Toxic skin eruption  1  1/317 (0.32%)  0/155 (0.00%) 
Urticaria  1  4/317 (1.26%)  0/155 (0.00%) 
Vascular disorders     
Aortic stenosis  1  1/317 (0.32%)  0/155 (0.00%) 
Deep vein thrombosis  1  2/317 (0.63%)  1/155 (0.65%) 
Embolism  1  1/317 (0.32%)  0/155 (0.00%) 
Hypotension  1  3/317 (0.95%)  1/155 (0.65%) 
Hypovolaemic shock  1  1/317 (0.32%)  0/155 (0.00%) 
Internal haemorrhage  1  0/317 (0.00%)  1/155 (0.65%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   315/317 (99.37%)   147/155 (94.84%) 
Blood and lymphatic system disorders     
Anaemia  1  51/317 (16.09%)  18/155 (11.61%) 
Leukopenia  1  18/317 (5.68%)  7/155 (4.52%) 
Neutropenia  1  122/317 (38.49%)  54/155 (34.84%) 
Thrombocytopenia  1  37/317 (11.67%)  18/155 (11.61%) 
Gastrointestinal disorders     
Abdominal pain  1  39/317 (12.30%)  11/155 (7.10%) 
Abdominal pain upper  1  21/317 (6.62%)  10/155 (6.45%) 
Constipation  1  74/317 (23.34%)  31/155 (20.00%) 
Diarrhoea  1  158/317 (49.84%)  33/155 (21.29%) 
Dry mouth  1  20/317 (6.31%)  3/155 (1.94%) 
Dyspepsia  1  28/317 (8.83%)  9/155 (5.81%) 
Gastrooesophageal reflux disease  1  17/317 (5.36%)  6/155 (3.87%) 
Mouth ulceration  1  20/317 (6.31%)  4/155 (2.58%) 
Nausea  1  159/317 (50.16%)  65/155 (41.94%) 
Stomatitis  1  26/317 (8.20%)  5/155 (3.23%) 
Vomiting  1  100/317 (31.55%)  25/155 (16.13%) 
General disorders     
Asthenia  1  43/317 (13.56%)  24/155 (15.48%) 
Chills  1  39/317 (12.30%)  10/155 (6.45%) 
Fatigue  1  103/317 (32.49%)  51/155 (32.90%) 
Mucosal inflammation  1  29/317 (9.15%)  2/155 (1.29%) 
Oedema peripheral  1  38/317 (11.99%)  7/155 (4.52%) 
Pyrexia  1  135/317 (42.59%)  22/155 (14.19%) 
Infections and infestations     
Bronchitis  1  22/317 (6.94%)  13/155 (8.39%) 
Herpes zoster  1  19/317 (5.99%)  7/155 (4.52%) 
Lower respiratory tract infection  1  14/317 (4.42%)  9/155 (5.81%) 
Nasopharyngitis  1  17/317 (5.36%)  14/155 (9.03%) 
Oral candidiasis  1  17/317 (5.36%)  2/155 (1.29%) 
Pneumonia  1  16/317 (5.05%)  2/155 (1.29%) 
Sinusitis  1  18/317 (5.68%)  11/155 (7.10%) 
Upper respiratory tract infection  1  58/317 (18.30%)  25/155 (16.13%) 
Urinary tract infection  1  26/317 (8.20%)  8/155 (5.16%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  38/317 (11.99%)  16/155 (10.32%) 
Investigations     
Alanine aminotransferase increased  1  65/317 (20.50%)  3/155 (1.94%) 
Aspartate aminotransferase increased  1  51/317 (16.09%)  4/155 (2.58%) 
Neutrophil count decreased  1  12/317 (3.79%)  9/155 (5.81%) 
Weight decreased  1  41/317 (12.93%)  6/155 (3.87%) 
Metabolism and nutrition disorders     
Decreased appetite  1  65/317 (20.50%)  25/155 (16.13%) 
Hypokalaemia  1  52/317 (16.40%)  11/155 (7.10%) 
Hypomagnesaemia  1  19/317 (5.99%)  2/155 (1.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  22/317 (6.94%)  12/155 (7.74%) 
Back pain  1  23/317 (7.26%)  12/155 (7.74%) 
Musculoskeletal pain  1  8/317 (2.52%)  8/155 (5.16%) 
Myalgia  1  21/317 (6.62%)  6/155 (3.87%) 
Pain in extremity  1  11/317 (3.47%)  8/155 (5.16%) 
Nervous system disorders     
Dizziness  1  23/317 (7.26%)  10/155 (6.45%) 
Dysgeusia  1  16/317 (5.05%)  10/155 (6.45%) 
Headache  1  45/317 (14.20%)  18/155 (11.61%) 
Neuropathy peripheral  1  8/317 (2.52%)  9/155 (5.81%) 
Paraesthesia  1  9/317 (2.84%)  9/155 (5.81%) 
Psychiatric disorders     
Insomnia  1  40/317 (12.62%)  16/155 (10.32%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  71/317 (22.40%)  37/155 (23.87%) 
Dyspnoea  1  40/317 (12.62%)  11/155 (7.10%) 
Oropharyngeal pain  1  25/317 (7.89%)  10/155 (6.45%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  20/317 (6.31%)  5/155 (3.23%) 
Erythema  1  20/317 (6.31%)  4/155 (2.58%) 
Night sweats  1  16/317 (5.05%)  6/155 (3.87%) 
Pruritus  1  54/317 (17.03%)  22/155 (14.19%) 
Rash  1  105/317 (33.12%)  16/155 (10.32%) 
Rash maculo-papular  1  29/317 (9.15%)  5/155 (3.23%) 
Urticaria  1  16/317 (5.05%)  4/155 (2.58%) 
Vascular disorders     
Hypotension  1  16/317 (5.05%)  5/155 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732926     History of Changes
Other Study ID Numbers: GS-US-313-0125
2012-004034-42 ( EudraCT Number )
First Submitted: November 14, 2012
First Posted: November 26, 2012
Results First Submitted: March 30, 2017
Results First Posted: May 11, 2017
Last Update Posted: November 16, 2018