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Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01980888
Recruitment Status : Terminated
First Posted : November 11, 2013
Results First Posted : October 11, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Idelalisib
Drug: Bendamustine
Drug: Rituximab
Drug: Placebo
Enrollment 311
Recruitment Details 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.
Pre-assignment Details 392 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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) 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)
Period Title: Overall Study
Started 157 154
Completed 13 [1] 21 [1]
Not Completed 144 133
Reason Not Completed
Study Terminated by Sponsor             116             122
Withdrew Consent             17             6
Investigator's Discretion             8             3
Non-Compliance with Study Drug             3             2
[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 (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) 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) Total of all reporting groups
Overall Number of Baseline Participants 157 154 311
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 154 participants 311 participants
64  (8.7) 63  (10.0) 64  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Female
57
  36.3%
48
  31.2%
105
  33.8%
Male
100
  63.7%
106
  68.8%
206
  66.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Asian
1
   0.6%
0
   0.0%
1
   0.3%
Black or African American
1
   0.6%
1
   0.6%
2
   0.6%
White
152
  96.8%
150
  97.4%
302
  97.1%
Other
3
   1.9%
1
   0.6%
4
   1.3%
Not Permitted
0
   0.0%
2
   1.3%
2
   0.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Hispanic or Latino
11
   7.0%
2
   1.3%
13
   4.2%
Not Hispanic or Latino
146
  93.0%
149
  96.8%
295
  94.9%
Not Permitted
0
   0.0%
3
   1.9%
3
   1.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Romania 4 1 5
Hungary 24 21 45
United States 35 25 60
United Kingdom 7 13 20
Spain 19 15 34
Canada 11 8 19
Czech Republic 10 17 27
Belgium 3 3 6
Poland 15 18 33
Italy 5 3 8
Australia 15 19 34
France 4 5 9
Croatia 5 6 11
Rai Stage at Screening   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Stage I
28
  17.8%
30
  19.5%
58
  18.6%
Stage II
66
  42.0%
58
  37.7%
124
  39.9%
Stage III
25
  15.9%
32
  20.8%
57
  18.3%
Stage IV
38
  24.2%
34
  22.1%
72
  23.2%
[1]
Measure Description:

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.

IgHV Mutation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Mutated
54
  34.4%
54
  35.1%
108
  34.7%
Unmutated
102
  65.0%
100
  64.9%
202
  65.0%
Missing
1
   0.6%
0
   0.0%
1
   0.3%
[1]
Measure Description: 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.
17p Deletion in CLL Cells   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Absent
146
  93.0%
145
  94.2%
291
  93.6%
Present
10
   6.4%
9
   5.8%
19
   6.1%
Missing
1
   0.6%
0
   0.0%
1
   0.3%
[1]
Measure Description: 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.
1.Primary Outcome
Title Progression-Free Survival
Hide Description 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).
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description

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.

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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
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)
Overall Number of Participants Analyzed 157 154
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(19.3 to NA)
NA [1] 
(19.6 to NA)
[1]
NA: not reached
2.Secondary Outcome
Title Overall Response Rate
Hide Description 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.
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
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)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Nodal Response Rate
Hide Description 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.
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
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)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Complete Response Rate
Hide Description 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.
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
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)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
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)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Minimal Residual Disease Negativity Rate at Week 36
Hide Description 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.
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
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)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 22 months plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
 
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 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions) 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)
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   113/156 (72.44%)   68/154 (44.16%) 
Blood and lymphatic system disorders     
Anaemia  1  8/156 (5.13%)  2/154 (1.30%) 
Bone marrow failure  1  1/156 (0.64%)  0/154 (0.00%) 
Febrile neutropenia  1  29/156 (18.59%)  16/154 (10.39%) 
Haemolytic anaemia  1  1/156 (0.64%)  0/154 (0.00%) 
Lymphadenopathy mediastinal  1  0/156 (0.00%)  1/154 (0.65%) 
Neutropenia  1  7/156 (4.49%)  1/154 (0.65%) 
Thrombocytopenia  1  2/156 (1.28%)  1/154 (0.65%) 
Cardiac disorders     
Acute myocardial infarction  1  0/156 (0.00%)  2/154 (1.30%) 
Arrhythmia  1  0/156 (0.00%)  1/154 (0.65%) 
Atrial fibrillation  1  4/156 (2.56%)  3/154 (1.95%) 
Cardiac failure  1  1/156 (0.64%)  2/154 (1.30%) 
Cardiac failure chronic  1  0/156 (0.00%)  1/154 (0.65%) 
Cardiac failure congestive  1  1/156 (0.64%)  0/154 (0.00%) 
Cardiopulmonary failure  1  1/156 (0.64%)  1/154 (0.65%) 
Coronary artery disease  1  1/156 (0.64%)  0/154 (0.00%) 
Myocardial ischaemia  1  0/156 (0.00%)  1/154 (0.65%) 
Supraventricular extrasystoles  1  0/156 (0.00%)  1/154 (0.65%) 
Ventricular extrasystoles  1  0/156 (0.00%)  1/154 (0.65%) 
Endocrine disorders     
Glucocorticoid deficiency  1  0/156 (0.00%)  1/154 (0.65%) 
Eye disorders     
Blindness  1  1/156 (0.64%)  0/154 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  1/156 (0.64%)  0/154 (0.00%) 
Colitis ulcerative  1  1/156 (0.64%)  0/154 (0.00%) 
Diarrhoea  1  6/156 (3.85%)  1/154 (0.65%) 
Enterocolitis  1  2/156 (1.28%)  0/154 (0.00%) 
Gastritis  1  0/156 (0.00%)  1/154 (0.65%) 
Haematochezia  1  0/156 (0.00%)  1/154 (0.65%) 
Oesophagitis  1  1/156 (0.64%)  0/154 (0.00%) 
Pancreatitis  1  0/156 (0.00%)  1/154 (0.65%) 
Pancreatitis acute  1  0/156 (0.00%)  1/154 (0.65%) 
Small intestinal obstruction  1  1/156 (0.64%)  0/154 (0.00%) 
Vomiting  1  1/156 (0.64%)  1/154 (0.65%) 
General disorders     
Asthenia  1  1/156 (0.64%)  0/154 (0.00%) 
Chest pain  1  0/156 (0.00%)  1/154 (0.65%) 
Influenza like illness  1  1/156 (0.64%)  0/154 (0.00%) 
Mucosal inflammation  1  1/156 (0.64%)  0/154 (0.00%) 
Oedema peripheral  1  1/156 (0.64%)  0/154 (0.00%) 
Pyrexia  1  26/156 (16.67%)  19/154 (12.34%) 
Systemic inflammatory response syndrome  1  0/156 (0.00%)  1/154 (0.65%) 
Unevaluable event  1  0/156 (0.00%)  1/154 (0.65%) 
Hepatobiliary disorders     
Cholecystitis  1  1/156 (0.64%)  0/154 (0.00%) 
Cholecystitis acute  1  0/156 (0.00%)  1/154 (0.65%) 
Hepatitis  1  1/156 (0.64%)  0/154 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  2/156 (1.28%)  0/154 (0.00%) 
Drug hypersensitivity  1  0/156 (0.00%)  3/154 (1.95%) 
Hypersensitivity  1  0/156 (0.00%)  1/154 (0.65%) 
Serum sickness  1  1/156 (0.64%)  0/154 (0.00%) 
Infections and infestations     
Appendicitis  1  1/156 (0.64%)  0/154 (0.00%) 
Bronchitis  1  1/156 (0.64%)  0/154 (0.00%) 
Cellulitis  1  1/156 (0.64%)  1/154 (0.65%) 
Cytomegalovirus gastritis  1  1/156 (0.64%)  0/154 (0.00%) 
Cytomegalovirus infection  1  3/156 (1.92%)  0/154 (0.00%) 
Cytomegalovirus viraemia  1  1/156 (0.64%)  0/154 (0.00%) 
Device related infection  1  2/156 (1.28%)  0/154 (0.00%) 
Gastroenteritis  1  1/156 (0.64%)  0/154 (0.00%) 
Gastrointestinal bacterial infection  1  1/156 (0.64%)  0/154 (0.00%) 
Herpes simplex  1  1/156 (0.64%)  0/154 (0.00%) 
Herpes zoster  1  1/156 (0.64%)  0/154 (0.00%) 
Infective exacerbation of chronic obstructive airways disease  1  0/156 (0.00%)  1/154 (0.65%) 
Influenza  1  2/156 (1.28%)  0/154 (0.00%) 
Lower respiratory tract infection  1  2/156 (1.28%)  1/154 (0.65%) 
Myocarditis infectious  1  1/156 (0.64%)  0/154 (0.00%) 
Neutropenic sepsis  1  5/156 (3.21%)  1/154 (0.65%) 
Pneumocystis jirovecii pneumonia  1  1/156 (0.64%)  0/154 (0.00%) 
Pneumonia  1  11/156 (7.05%)  6/154 (3.90%) 
Pneumonia fungal  1  1/156 (0.64%)  0/154 (0.00%) 
Respiratory tract infection  1  3/156 (1.92%)  1/154 (0.65%) 
Sepsis  1  9/156 (5.77%)  2/154 (1.30%) 
Septic shock  1  1/156 (0.64%)  0/154 (0.00%) 
Staphylococcal sepsis  1  1/156 (0.64%)  0/154 (0.00%) 
Strongyloidiasis  1  0/156 (0.00%)  1/154 (0.65%) 
Tonsillitis  1  0/156 (0.00%)  1/154 (0.65%) 
Upper respiratory tract infection  1  1/156 (0.64%)  1/154 (0.65%) 
Urinary tract infection  1  4/156 (2.56%)  1/154 (0.65%) 
Varicella zoster virus infection  1  1/156 (0.64%)  0/154 (0.00%) 
Viral infection  1  0/156 (0.00%)  1/154 (0.65%) 
Injury, poisoning and procedural complications     
Fall  1  0/156 (0.00%)  1/154 (0.65%) 
Hip fracture  1  0/156 (0.00%)  1/154 (0.65%) 
Infusion related reaction  1  3/156 (1.92%)  1/154 (0.65%) 
Procedural complication  1  0/156 (0.00%)  1/154 (0.65%) 
Investigations     
Alanine aminotransferase increased  1  2/156 (1.28%)  0/154 (0.00%) 
Aspartate aminotransferase increased  1  2/156 (1.28%)  0/154 (0.00%) 
General physical condition abnormal  1  1/156 (0.64%)  0/154 (0.00%) 
Transaminases increased  1  2/156 (1.28%)  0/154 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/156 (0.64%)  0/154 (0.00%) 
Dehydration  1  3/156 (1.92%)  1/154 (0.65%) 
Hypokalaemia  1  0/156 (0.00%)  1/154 (0.65%) 
Malnutrition  1  1/156 (0.64%)  0/154 (0.00%) 
Tumour lysis syndrome  1  5/156 (3.21%)  4/154 (2.60%) 
Musculoskeletal and connective tissue disorders     
Compartment syndrome  1  1/156 (0.64%)  0/154 (0.00%) 
Diabetic amyotrophy  1  0/156 (0.00%)  1/154 (0.65%) 
Musculoskeletal chest pain  1  0/156 (0.00%)  1/154 (0.65%) 
Spinal column stenosis  1  0/156 (0.00%)  1/154 (0.65%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant ascites  1  0/156 (0.00%)  1/154 (0.65%) 
Malignant melanoma  1  1/156 (0.64%)  0/154 (0.00%) 
Malignant pleural effusion  1  0/156 (0.00%)  1/154 (0.65%) 
Meningioma  1  1/156 (0.64%)  0/154 (0.00%) 
Metastatic squamous cell carcinoma  1  1/156 (0.64%)  0/154 (0.00%) 
Skin cancer  1  1/156 (0.64%)  0/154 (0.00%) 
Squamous cell carcinoma  1  1/156 (0.64%)  0/154 (0.00%) 
Squamous cell carcinoma of lung  1  0/156 (0.00%)  1/154 (0.65%) 
Nervous system disorders     
Dysarthria  1  0/156 (0.00%)  1/154 (0.65%) 
Encephalopathy  1  1/156 (0.64%)  0/154 (0.00%) 
Facial paralysis  1  0/156 (0.00%)  1/154 (0.65%) 
Ischaemic stroke  1  0/156 (0.00%)  1/154 (0.65%) 
Syncope  1  2/156 (1.28%)  0/154 (0.00%) 
Transient ischaemic attack  1  2/156 (1.28%)  0/154 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/156 (0.64%)  0/154 (0.00%) 
Confusional state  1  1/156 (0.64%)  0/154 (0.00%) 
Depression  1  1/156 (0.64%)  0/154 (0.00%) 
Hallucination, auditory  1  1/156 (0.64%)  0/154 (0.00%) 
Mental status changes  1  1/156 (0.64%)  0/154 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  2/156 (1.28%)  0/154 (0.00%) 
Prerenal failure  1  1/156 (0.64%)  0/154 (0.00%) 
Renal tubular acidosis  1  1/156 (0.64%)  0/154 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/156 (0.64%)  0/154 (0.00%) 
Dyspnoea  1  0/156 (0.00%)  1/154 (0.65%) 
Pleural effusion  1  1/156 (0.64%)  0/154 (0.00%) 
Pneumonitis  1  5/156 (3.21%)  3/154 (1.95%) 
Procedural pneumothorax  1  0/156 (0.00%)  1/154 (0.65%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  0/156 (0.00%)  1/154 (0.65%) 
Drug eruption  1  1/156 (0.64%)  0/154 (0.00%) 
Generalised erythema  1  2/156 (1.28%)  1/154 (0.65%) 
Photosensitivity reaction  1  0/156 (0.00%)  1/154 (0.65%) 
Rash  1  4/156 (2.56%)  1/154 (0.65%) 
Rash generalised  1  1/156 (0.64%)  1/154 (0.65%) 
Rash maculo-papular  1  2/156 (1.28%)  0/154 (0.00%) 
Vascular disorders     
Aortitis  1  1/156 (0.64%)  0/154 (0.00%) 
Embolism  1  1/156 (0.64%)  0/154 (0.00%) 
Haematoma  1  1/156 (0.64%)  0/154 (0.00%) 
Peripheral embolism  1  1/156 (0.64%)  0/154 (0.00%) 
Thrombophlebitis  1  0/156 (0.00%)  1/154 (0.65%) 
Thrombophlebitis superficial  1  0/156 (0.00%)  1/154 (0.65%) 
Thrombosis  1  1/156 (0.64%)  0/154 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 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   154/156 (98.72%)   150/154 (97.40%) 
Blood and lymphatic system disorders     
Anaemia  1  40/156 (25.64%)  29/154 (18.83%) 
Neutropenia  1  84/156 (53.85%)  90/154 (58.44%) 
Thrombocytopenia  1  19/156 (12.18%)  16/154 (10.39%) 
Cardiac disorders     
Atrial fibrillation  1  8/156 (5.13%)  3/154 (1.95%) 
Gastrointestinal disorders     
Abdominal pain  1  14/156 (8.97%)  14/154 (9.09%) 
Constipation  1  26/156 (16.67%)  34/154 (22.08%) 
Diarrhoea  1  63/156 (40.38%)  46/154 (29.87%) 
Dry mouth  1  11/156 (7.05%)  4/154 (2.60%) 
Dyspepsia  1  15/156 (9.62%)  12/154 (7.79%) 
Gastrooesophageal reflux disease  1  9/156 (5.77%)  4/154 (2.60%) 
Nausea  1  61/156 (39.10%)  63/154 (40.91%) 
Stomatitis  1  10/156 (6.41%)  4/154 (2.60%) 
Vomiting  1  37/156 (23.72%)  23/154 (14.94%) 
General disorders     
Asthenia  1  21/156 (13.46%)  9/154 (5.84%) 
Chills  1  21/156 (13.46%)  14/154 (9.09%) 
Fatigue  1  43/156 (27.56%)  44/154 (28.57%) 
Mucosal inflammation  1  14/156 (8.97%)  1/154 (0.65%) 
Oedema peripheral  1  19/156 (12.18%)  16/154 (10.39%) 
Pyrexia  1  71/156 (45.51%)  38/154 (24.68%) 
Immune system disorders     
Drug hypersensitivity  1  8/156 (5.13%)  2/154 (1.30%) 
Infections and infestations     
Bronchitis  1  5/156 (3.21%)  8/154 (5.19%) 
Influenza  1  6/156 (3.85%)  8/154 (5.19%) 
Nasopharyngitis  1  8/156 (5.13%)  14/154 (9.09%) 
Oral candidiasis  1  8/156 (5.13%)  4/154 (2.60%) 
Oral herpes  1  5/156 (3.21%)  8/154 (5.19%) 
Pneumonia  1  10/156 (6.41%)  3/154 (1.95%) 
Respiratory tract infection  1  9/156 (5.77%)  4/154 (2.60%) 
Sinusitis  1  9/156 (5.77%)  4/154 (2.60%) 
Upper respiratory tract infection  1  25/156 (16.03%)  21/154 (13.64%) 
Urinary tract infection  1  15/156 (9.62%)  6/154 (3.90%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  21/156 (13.46%)  33/154 (21.43%) 
Investigations     
Alanine aminotransferase increased  1  22/156 (14.10%)  3/154 (1.95%) 
Aspartate aminotransferase increased  1  18/156 (11.54%)  2/154 (1.30%) 
Neutrophil count decreased  1  8/156 (5.13%)  2/154 (1.30%) 
Weight decreased  1  19/156 (12.18%)  4/154 (2.60%) 
Metabolism and nutrition disorders     
Decreased appetite  1  26/156 (16.67%)  21/154 (13.64%) 
Dehydration  1  12/156 (7.69%)  2/154 (1.30%) 
Hypokalaemia  1  25/156 (16.03%)  4/154 (2.60%) 
Hypophosphataemia  1  9/156 (5.77%)  0/154 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  16/156 (10.26%)  12/154 (7.79%) 
Back pain  1  11/156 (7.05%)  18/154 (11.69%) 
Nervous system disorders     
Dizziness  1  13/156 (8.33%)  13/154 (8.44%) 
Dysgeusia  1  10/156 (6.41%)  11/154 (7.14%) 
Headache  1  16/156 (10.26%)  25/154 (16.23%) 
Psychiatric disorders     
Anxiety  1  11/156 (7.05%)  9/154 (5.84%) 
Depression  1  8/156 (5.13%)  2/154 (1.30%) 
Insomnia  1  17/156 (10.90%)  12/154 (7.79%) 
Renal and urinary disorders     
Dysuria  1  9/156 (5.77%)  3/154 (1.95%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  34/156 (21.79%)  29/154 (18.83%) 
Dyspnoea  1  24/156 (15.38%)  12/154 (7.79%) 
Oropharyngeal pain  1  8/156 (5.13%)  9/154 (5.84%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  14/156 (8.97%)  4/154 (2.60%) 
Erythema  1  12/156 (7.69%)  8/154 (5.19%) 
Pruritus  1  24/156 (15.38%)  32/154 (20.78%) 
Rash  1  63/156 (40.38%)  34/154 (22.08%) 
Rash macular  1  8/156 (5.13%)  2/154 (1.30%) 
Rash maculo-papular  1  29/156 (18.59%)  12/154 (7.79%) 
Vascular disorders     
Hypotension  1  11/156 (7.05%)  10/154 (6.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
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.
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: NCT01980888     History of Changes
Other Study ID Numbers: GS-US-312-0123
2013-003313-17 ( EudraCT Number )
First Submitted: November 5, 2013
First Posted: November 11, 2013
Results First Submitted: March 30, 2017
Results First Posted: October 11, 2017
Last Update Posted: November 19, 2018