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Efficacy and Safety of Idelalisib (GS-1101; CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01659021
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : March 31, 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: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Idelalisib
Drug: Ofatumumab
Enrollment 261
Recruitment Details Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 04 December 2012. The last study visit up to the data cut date occurred on 02 May 2016.
Pre-assignment Details 310 participants were screened.
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Period Title: Overall Study
Started 174 87
Randomized and Treated 173 86
Completed 86 50
Not Completed 88 37
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             1             0
Other?             1             1
Physician Decision             32             16
Withdrawal by Subject             18             16
Still on Study             34             1
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab Total
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Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Total of all reporting groups
Overall Number of Baseline Participants 174 87 261
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: participants who are randomized in the study with treatment group designated according to initial randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 174 participants 87 participants 261 participants
67  (9.0) 67  (9.7) 67  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 87 participants 261 participants
Female
50
  28.7%
25
  28.7%
75
  28.7%
Male
124
  71.3%
62
  71.3%
186
  71.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 87 participants 261 participants
Hispanic or Latino
7
   4.0%
3
   3.4%
10
   3.8%
Not Hispanic or Latino
141
  81.0%
74
  85.1%
215
  82.4%
Unknown or Not Reported
26
  14.9%
10
  11.5%
36
  13.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 174 participants 87 participants 261 participants
149
  85.6%
71
  81.6%
220
  84.3%
Black or African American Number Analyzed 174 participants 87 participants 261 participants
0
   0.0%
4
   4.6%
4
   1.5%
Native Hawaiian or Other Pacific Islander Number Analyzed 174 participants 87 participants 261 participants
1
   0.6%
0
   0.0%
1
   0.4%
Asian Number Analyzed 174 participants 87 participants 261 participants
2
   1.1%
0
   0.0%
2
   0.8%
Other Number Analyzed 174 participants 87 participants 261 participants
2
   1.1%
3
   3.4%
5
   1.9%
Not Permitted Number Analyzed 174 participants 87 participants 261 participants
20
  11.5%
9
  10.3%
29
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 174 participants 87 participants 261 participants
13 9 22
Sweden Number Analyzed 174 participants 87 participants 261 participants
4 2 6
Belgium Number Analyzed 174 participants 87 participants 261 participants
5 1 6
United States Number Analyzed 174 participants 87 participants 261 participants
64 29 93
Ireland Number Analyzed 174 participants 87 participants 261 participants
7 4 11
Denmark Number Analyzed 174 participants 87 participants 261 participants
4 0 4
Poland Number Analyzed 174 participants 87 participants 261 participants
27 9 36
United Kingdom Number Analyzed 174 participants 87 participants 261 participants
11 6 17
Australia Number Analyzed 174 participants 87 participants 261 participants
16 13 29
France Number Analyzed 174 participants 87 participants 261 participants
15 9 24
Spain Number Analyzed 174 participants 87 participants 261 participants
8 5 13
Time Since Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 173 participants 86 participants 259 participants
101.0  (60.21) 94.3  (52.51) 98.8  (57.75)
[1]
Measure Analysis Population Description: Only participants who were randomized and treated are included.
17p deletion and/or TP53 mutation  
Measure Type: Count of Participants
Unit of measure:  Participants
Either Number Analyzed 174 participants 87 participants 261 participants
70
  40.2%
33
  37.9%
103
  39.5%
Neither Number Analyzed 174 participants 87 participants 261 participants
104
  59.8%
54
  62.1%
158
  60.5%
Immunoglobulin heavy chain variable region (IGHV) mutation status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 87 participants 261 participants
Mutated
37
  21.3%
19
  21.8%
56
  21.5%
Unmutated
137
  78.7%
68
  78.2%
205
  78.5%
Disease Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Refractory Number Analyzed 174 participants 87 participants 261 participants
82
  47.1%
47
  54.0%
129
  49.4%
Relapsed Number Analyzed 174 participants 87 participants 261 participants
92
  52.9%
40
  46.0%
132
  50.6%
[1]
Measure Description: Refractory: CLL progression < 6 months from completion of prior therapy; Relapsed: CLL progression ≥ 6 months from completion of prior therapy.
1.Primary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
Time Frame Up to 37 months
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Hide Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: participants who are randomized in the study with treatment group designated according to initial randomization.
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description:

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Overall Number of Participants Analyzed 174 87
Median (95% Confidence Interval)
Unit of Measure: months
16.6
(13.6 to 21.7)
8.0
(5.7 to 8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Idelalisib+Ofatumumab, Ofatumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, IGHV mutation, and disease status).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.17 to 0.35
Estimation Comments Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.
2.Secondary Outcome
Title Overall Response Rate
Hide Description

Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

  • Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
  • Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.
Time Frame Up to 37 months
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Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description:

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Overall Number of Participants Analyzed 174 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.3
(68.2 to 81.5)
18.4
(10.9 to 28.1)
3.Secondary Outcome
Title Lymph Node Response Rate
Hide Description Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.
Time Frame Up to 37 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed.
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description:

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Overall Number of Participants Analyzed 164 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.7
(87.6 to 96.2)
4.9
(1.4 to 12.2)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the interval from randomization to death from any cause.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description:

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Overall Number of Participants Analyzed 174 87
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(31.5 to NA)
30.2 [1] 
(23.0 to NA)
[1]
NA = Not reached due to insufficient number of events
5.Secondary Outcome
Title Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
Hide Description [Not Specified]
Time Frame Up to 37 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with chromosome 17p deletion and/or TP53 mutation were analyzed.
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description:

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Participants in this group had 17p deletion and/or TP53 mutation.

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Participants in this group had 17p deletion and/or TP53 mutation.

Overall Number of Participants Analyzed 70 33
Median (95% Confidence Interval)
Unit of Measure: months
15.5
(11.1 to 19.1)
5.8
(4.5 to 8.4)
6.Secondary Outcome
Title Complete Response Rate
Hide Description Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).
Time Frame Up to 37 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description:

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Overall Number of Participants Analyzed 174 87
Measure Type: Number
Unit of Measure: percentage of participants
1.1 0
Time Frame Baseline up to the last dose date plus 30 days (maximum: 38 months)
Adverse Event Reporting Description Safety Analysis Set: participants who received ≥ 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
 
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab
Hide Arm/Group Description

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

All-Cause Mortality
Idelalisib+Ofatumumab Ofatumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib+Ofatumumab Ofatumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   133/173 (76.88%)   36/86 (41.86%) 
Blood and lymphatic system disorders     
Anaemia  1  8/173 (4.62%)  2/86 (2.33%) 
Autoimmune haemolytic anaemia  1  1/173 (0.58%)  0/86 (0.00%) 
Disseminated intravascular coagulation  1  1/173 (0.58%)  0/86 (0.00%) 
Febrile neutropenia  1  19/173 (10.98%)  3/86 (3.49%) 
Granulocytopenia  1  2/173 (1.16%)  0/86 (0.00%) 
Leukocytosis  1  1/173 (0.58%)  0/86 (0.00%) 
Lymphadenopathy  1  0/173 (0.00%)  1/86 (1.16%) 
Neutropenia  1  12/173 (6.94%)  2/86 (2.33%) 
Pancytopenia  1  2/173 (1.16%)  0/86 (0.00%) 
Thrombocytopenia  1  5/173 (2.89%)  2/86 (2.33%) 
Cardiac disorders     
Acute coronary syndrome  1  0/173 (0.00%)  1/86 (1.16%) 
Acute myocardial infarction  1  2/173 (1.16%)  0/86 (0.00%) 
Arrhythmia  1  1/173 (0.58%)  0/86 (0.00%) 
Atrial fibrillation  1  3/173 (1.73%)  2/86 (2.33%) 
Bradycardia  1  1/173 (0.58%)  0/86 (0.00%) 
Cardiac arrest  1  1/173 (0.58%)  0/86 (0.00%) 
Cardiac failure  1  1/173 (0.58%)  0/86 (0.00%) 
Cardiogenic shock  1  2/173 (1.16%)  0/86 (0.00%) 
Myocardial infarction  1  2/173 (1.16%)  0/86 (0.00%) 
Myocardial ischaemia  1  1/173 (0.58%)  0/86 (0.00%) 
Palpitations  1  0/173 (0.00%)  1/86 (1.16%) 
Right ventricular failure  1  1/173 (0.58%)  0/86 (0.00%) 
Ear and labyrinth disorders     
External ear inflammation  1  1/173 (0.58%)  0/86 (0.00%) 
Vertigo  1  1/173 (0.58%)  0/86 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  7/173 (4.05%)  1/86 (1.16%) 
Abdominal pain upper  1  0/173 (0.00%)  1/86 (1.16%) 
Abdominal wall haematoma  1  1/173 (0.58%)  0/86 (0.00%) 
Anal fistula  1  0/173 (0.00%)  1/86 (1.16%) 
Colitis  1  13/173 (7.51%)  0/86 (0.00%) 
Colitis ulcerative  1  1/173 (0.58%)  0/86 (0.00%) 
Diarrhoea  1  21/173 (12.14%)  0/86 (0.00%) 
Dysphagia  1  1/173 (0.58%)  0/86 (0.00%) 
Gastric haemorrhage  1  1/173 (0.58%)  0/86 (0.00%) 
Intestinal obstruction  1  0/173 (0.00%)  1/86 (1.16%) 
Large intestine perforation  1  1/173 (0.58%)  0/86 (0.00%) 
Mouth haemorrhage  1  1/173 (0.58%)  0/86 (0.00%) 
Nausea  1  3/173 (1.73%)  0/86 (0.00%) 
Stomatitis  1  2/173 (1.16%)  0/86 (0.00%) 
Vomiting  1  3/173 (1.73%)  0/86 (0.00%) 
General disorders     
Asthenia  1  2/173 (1.16%)  1/86 (1.16%) 
Chest pain  1  2/173 (1.16%)  0/86 (0.00%) 
Death  1  1/173 (0.58%)  0/86 (0.00%) 
General physical health deterioration  1  1/173 (0.58%)  0/86 (0.00%) 
Generalised oedema  1  0/173 (0.00%)  1/86 (1.16%) 
Impaired self-care  1  1/173 (0.58%)  0/86 (0.00%) 
Influenza like illness  1  1/173 (0.58%)  0/86 (0.00%) 
Pyrexia  1  23/173 (13.29%)  1/86 (1.16%) 
Strangulated hernia  1  1/173 (0.58%)  0/86 (0.00%) 
Systemic inflammatory response syndrome  1  1/173 (0.58%)  0/86 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/173 (0.58%)  0/86 (0.00%) 
Cholecystitis  1  2/173 (1.16%)  0/86 (0.00%) 
Immune system disorders     
Anaphylactic shock  1  0/173 (0.00%)  1/86 (1.16%) 
Drug hypersensitivity  1  1/173 (0.58%)  0/86 (0.00%) 
Infections and infestations     
Abscess  1  0/173 (0.00%)  1/86 (1.16%) 
Aspergillus infection  1  1/173 (0.58%)  0/86 (0.00%) 
Atypical pneumonia  1  2/173 (1.16%)  0/86 (0.00%) 
Bacteraemia  1  2/173 (1.16%)  0/86 (0.00%) 
Bacterial sepsis  1  1/173 (0.58%)  0/86 (0.00%) 
Biliary sepsis  1  1/173 (0.58%)  0/86 (0.00%) 
Bronchitis  1  4/173 (2.31%)  0/86 (0.00%) 
Bronchopulmonary aspergillosis  1  1/173 (0.58%)  0/86 (0.00%) 
Candida infection  1  1/173 (0.58%)  0/86 (0.00%) 
Candida pneumonia  1  0/173 (0.00%)  1/86 (1.16%) 
Candida sepsis  1  1/173 (0.58%)  0/86 (0.00%) 
Cellulitis  1  2/173 (1.16%)  0/86 (0.00%) 
Device related infection  1  0/173 (0.00%)  1/86 (1.16%) 
Escherichia bacteraemia  1  0/173 (0.00%)  1/86 (1.16%) 
Escherichia sepsis  1  1/173 (0.58%)  0/86 (0.00%) 
Escherichia urinary tract infection  1  0/173 (0.00%)  1/86 (1.16%) 
Folliculitis  1  1/173 (0.58%)  0/86 (0.00%) 
Gastroenteritis  1  1/173 (0.58%)  0/86 (0.00%) 
Gastroenteritis salmonella  1  1/173 (0.58%)  0/86 (0.00%) 
Genital herpes  1  1/173 (0.58%)  0/86 (0.00%) 
H1N1 influenza  1  0/173 (0.00%)  1/86 (1.16%) 
Herpes simplex  1  1/173 (0.58%)  0/86 (0.00%) 
Herpes zoster  1  1/173 (0.58%)  0/86 (0.00%) 
Herpes zoster disseminated  1  1/173 (0.58%)  0/86 (0.00%) 
Infective exacerbation of chronic obstructive airways disease  1  1/173 (0.58%)  0/86 (0.00%) 
Listeria sepsis  1  0/173 (0.00%)  1/86 (1.16%) 
Lower respiratory tract infection  1  5/173 (2.89%)  2/86 (2.33%) 
Lung infection  1  4/173 (2.31%)  0/86 (0.00%) 
Neutropenic sepsis  1  4/173 (2.31%)  2/86 (2.33%) 
Pneumocystis jirovecii infection  1  1/173 (0.58%)  1/86 (1.16%) 
Pneumocystis jirovecii pneumonia  1  8/173 (4.62%)  0/86 (0.00%) 
Pneumonia  1  25/173 (14.45%)  9/86 (10.47%) 
Progressive multifocal leukoencephalopathy  1  0/173 (0.00%)  2/86 (2.33%) 
Pseudomonal bacteraemia  1  2/173 (1.16%)  0/86 (0.00%) 
Pseudomonal sepsis  1  1/173 (0.58%)  0/86 (0.00%) 
Pseudomonas infection  1  0/173 (0.00%)  1/86 (1.16%) 
Respiratory syncytial virus bronchiolitis  1  1/173 (0.58%)  0/86 (0.00%) 
Respiratory tract infection  1  3/173 (1.73%)  2/86 (2.33%) 
Rhinovirus infection  1  1/173 (0.58%)  0/86 (0.00%) 
Salmonellosis  1  1/173 (0.58%)  0/86 (0.00%) 
Sepsis  1  11/173 (6.36%)  1/86 (1.16%) 
Septic shock  1  5/173 (2.89%)  1/86 (1.16%) 
Sinusitis  1  2/173 (1.16%)  0/86 (0.00%) 
Skin infection  1  0/173 (0.00%)  1/86 (1.16%) 
Urinary tract infection  1  7/173 (4.05%)  0/86 (0.00%) 
Urosepsis  1  1/173 (0.58%)  0/86 (0.00%) 
Varicella  1  0/173 (0.00%)  1/86 (1.16%) 
Viral infection  1  1/173 (0.58%)  0/86 (0.00%) 
Viral sepsis  1  1/173 (0.58%)  0/86 (0.00%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/173 (0.00%)  1/86 (1.16%) 
Femur fracture  1  0/173 (0.00%)  1/86 (1.16%) 
Infusion related reaction  1  2/173 (1.16%)  0/86 (0.00%) 
Overdose  1  2/173 (1.16%)  0/86 (0.00%) 
Upper limb fracture  1  0/173 (0.00%)  1/86 (1.16%) 
Investigations     
Alanine aminotransferase increased  1  1/173 (0.58%)  0/86 (0.00%) 
Aspartate aminotransferase increased  1  1/173 (0.58%)  0/86 (0.00%) 
Lymphocyte count decreased  1  1/173 (0.58%)  0/86 (0.00%) 
Neutrophil count decreased  1  6/173 (3.47%)  0/86 (0.00%) 
Platelet count decreased  1  1/173 (0.58%)  0/86 (0.00%) 
Transaminases increased  1  1/173 (0.58%)  0/86 (0.00%) 
Troponin increased  1  0/173 (0.00%)  1/86 (1.16%) 
Weight decreased  1  1/173 (0.58%)  1/86 (1.16%) 
White blood cell count decreased  1  1/173 (0.58%)  0/86 (0.00%) 
Metabolism and nutrition disorders     
Cachexia  1  1/173 (0.58%)  0/86 (0.00%) 
Dehydration  1  6/173 (3.47%)  0/86 (0.00%) 
Hypercalcaemia  1  2/173 (1.16%)  1/86 (1.16%) 
Hyperglycaemia  1  1/173 (0.58%)  0/86 (0.00%) 
Hyperkalaemia  1  3/173 (1.73%)  1/86 (1.16%) 
Hypokalaemia  1  4/173 (2.31%)  0/86 (0.00%) 
Hyponatraemia  1  2/173 (1.16%)  0/86 (0.00%) 
Hypophosphataemia  1  2/173 (1.16%)  0/86 (0.00%) 
Pseudohyperkalaemia  1  1/173 (0.58%)  0/86 (0.00%) 
Tumour lysis syndrome  1  1/173 (0.58%)  0/86 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/173 (1.16%)  0/86 (0.00%) 
Haemarthrosis  1  1/173 (0.58%)  0/86 (0.00%) 
Muscle haemorrhage  1  1/173 (0.58%)  0/86 (0.00%) 
Myalgia  1  1/173 (0.58%)  0/86 (0.00%) 
Pain in extremity  1  1/173 (0.58%)  0/86 (0.00%) 
Polyarthritis  1  1/173 (0.58%)  0/86 (0.00%) 
Soft tissue necrosis  1  1/173 (0.58%)  0/86 (0.00%) 
Tenosynovitis  1  1/173 (0.58%)  0/86 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/173 (0.58%)  0/86 (0.00%) 
Anogenital warts  1  1/173 (0.58%)  0/86 (0.00%) 
Basal cell carcinoma  1  2/173 (1.16%)  0/86 (0.00%) 
Colon cancer metastatic  1  1/173 (0.58%)  0/86 (0.00%) 
Invasive lobular breast carcinoma  1  1/173 (0.58%)  0/86 (0.00%) 
Malignant ascites  1  1/173 (0.58%)  0/86 (0.00%) 
Malignant melanoma  1  0/173 (0.00%)  1/86 (1.16%) 
Mycosis fungoides  1  1/173 (0.58%)  0/86 (0.00%) 
Non-small cell lung cancer  1  2/173 (1.16%)  0/86 (0.00%) 
Prostate cancer  1  1/173 (0.58%)  0/86 (0.00%) 
Renal neoplasm  1  1/173 (0.58%)  0/86 (0.00%) 
Squamous cell carcinoma  1  2/173 (1.16%)  0/86 (0.00%) 
Nervous system disorders     
Aphasia  1  1/173 (0.58%)  0/86 (0.00%) 
Central nervous system leukaemia  1  0/173 (0.00%)  1/86 (1.16%) 
Cerebral infarction  1  1/173 (0.58%)  0/86 (0.00%) 
Dizziness  1  1/173 (0.58%)  0/86 (0.00%) 
Embolic stroke  1  1/173 (0.58%)  0/86 (0.00%) 
Facial paralysis  1  1/173 (0.58%)  0/86 (0.00%) 
Hemiparesis  1  2/173 (1.16%)  0/86 (0.00%) 
Hypotonia  1  1/173 (0.58%)  0/86 (0.00%) 
Locked-in syndrome  1  1/173 (0.58%)  0/86 (0.00%) 
Peroneal nerve palsy  1  1/173 (0.58%)  0/86 (0.00%) 
Sciatica  1  1/173 (0.58%)  0/86 (0.00%) 
Transient ischaemic attack  1  2/173 (1.16%)  0/86 (0.00%) 
Product Issues     
Device occlusion  1  1/173 (0.58%)  0/86 (0.00%) 
Psychiatric disorders     
Bipolar I disorder  1  0/173 (0.00%)  1/86 (1.16%) 
Confusional state  1  1/173 (0.58%)  0/86 (0.00%) 
Mania  1  1/173 (0.58%)  0/86 (0.00%) 
Mental status changes  1  1/173 (0.58%)  0/86 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  5/173 (2.89%)  0/86 (0.00%) 
Acute prerenal failure  1  1/173 (0.58%)  0/86 (0.00%) 
Chronic kidney disease  1  1/173 (0.58%)  0/86 (0.00%) 
Haematuria  1  1/173 (0.58%)  0/86 (0.00%) 
Renal failure  1  3/173 (1.73%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/173 (1.16%)  0/86 (0.00%) 
Aspiration  1  1/173 (0.58%)  0/86 (0.00%) 
Bronchitis chronic  1  1/173 (0.58%)  0/86 (0.00%) 
Chronic obstructive pulmonary disease  1  1/173 (0.58%)  0/86 (0.00%) 
Cough  1  2/173 (1.16%)  0/86 (0.00%) 
Dyspnoea  1  4/173 (2.31%)  0/86 (0.00%) 
Interstitial lung disease  1  2/173 (1.16%)  0/86 (0.00%) 
Lower respiratory tract inflammation  1  1/173 (0.58%)  0/86 (0.00%) 
Pleural effusion  1  2/173 (1.16%)  0/86 (0.00%) 
Pneumonia aspiration  1  1/173 (0.58%)  0/86 (0.00%) 
Pneumonitis  1  7/173 (4.05%)  0/86 (0.00%) 
Pulmonary embolism  1  2/173 (1.16%)  0/86 (0.00%) 
Pulmonary fibrosis  1  1/173 (0.58%)  0/86 (0.00%) 
Pulmonary haemorrhage  1  1/173 (0.58%)  0/86 (0.00%) 
Pulmonary oedema  1  0/173 (0.00%)  1/86 (1.16%) 
Respiratory arrest  1  1/173 (0.58%)  0/86 (0.00%) 
Respiratory failure  1  6/173 (3.47%)  1/86 (1.16%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  1/173 (0.58%)  0/86 (0.00%) 
Rash  1  1/173 (0.58%)  0/86 (0.00%) 
Vascular disorders     
Haematoma  1  1/173 (0.58%)  0/86 (0.00%) 
Hypotension  1  7/173 (4.05%)  1/86 (1.16%) 
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+Ofatumumab Ofatumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   167/173 (96.53%)   79/86 (91.86%) 
Blood and lymphatic system disorders     
Anaemia  1  37/173 (21.39%)  7/86 (8.14%) 
Neutropenia  1  54/173 (31.21%)  14/86 (16.28%) 
Thrombocytopenia  1  24/173 (13.87%)  5/86 (5.81%) 
Cardiac disorders     
Tachycardia  1  10/173 (5.78%)  2/86 (2.33%) 
Gastrointestinal disorders     
Abdominal pain  1  28/173 (16.18%)  5/86 (5.81%) 
Abdominal pain upper  1  14/173 (8.09%)  4/86 (4.65%) 
Colitis  1  13/173 (7.51%)  0/86 (0.00%) 
Constipation  1  39/173 (22.54%)  13/86 (15.12%) 
Diarrhoea  1  92/173 (53.18%)  21/86 (24.42%) 
Dyspepsia  1  13/173 (7.51%)  3/86 (3.49%) 
Gastrooesophageal reflux disease  1  15/173 (8.67%)  3/86 (3.49%) 
Nausea  1  58/173 (33.53%)  23/86 (26.74%) 
Stomatitis  1  9/173 (5.20%)  0/86 (0.00%) 
Vomiting  1  28/173 (16.18%)  12/86 (13.95%) 
General disorders     
Asthenia  1  26/173 (15.03%)  9/86 (10.47%) 
Chest pain  1  9/173 (5.20%)  2/86 (2.33%) 
Chills  1  26/173 (15.03%)  13/86 (15.12%) 
Fatigue  1  58/173 (33.53%)  24/86 (27.91%) 
Influenza like illness  1  12/173 (6.94%)  1/86 (1.16%) 
Malaise  1  10/173 (5.78%)  1/86 (1.16%) 
Oedema peripheral  1  33/173 (19.08%)  9/86 (10.47%) 
Pain  1  12/173 (6.94%)  2/86 (2.33%) 
Peripheral swelling  1  11/173 (6.36%)  1/86 (1.16%) 
Pyrexia  1  53/173 (30.64%)  19/86 (22.09%) 
Immune system disorders     
Hypogammaglobulinaemia  1  11/173 (6.36%)  3/86 (3.49%) 
Infections and infestations     
Bronchitis  1  25/173 (14.45%)  0/86 (0.00%) 
Lower respiratory tract infection  1  11/173 (6.36%)  2/86 (2.33%) 
Oral candidiasis  1  15/173 (8.67%)  0/86 (0.00%) 
Oral herpes  1  10/173 (5.78%)  2/86 (2.33%) 
Pneumonia  1  17/173 (9.83%)  2/86 (2.33%) 
Sinusitis  1  22/173 (12.72%)  2/86 (2.33%) 
Upper respiratory tract infection  1  44/173 (25.43%)  9/86 (10.47%) 
Urinary tract infection  1  18/173 (10.40%)  6/86 (6.98%) 
Injury, poisoning and procedural complications     
Contusion  1  16/173 (9.25%)  3/86 (3.49%) 
Infusion related reaction  1  29/173 (16.76%)  23/86 (26.74%) 
Investigations     
Alanine aminotransferase increased  1  18/173 (10.40%)  2/86 (2.33%) 
Aspartate aminotransferase increased  1  13/173 (7.51%)  2/86 (2.33%) 
Neutrophil count decreased  1  16/173 (9.25%)  2/86 (2.33%) 
Weight decreased  1  25/173 (14.45%)  5/86 (5.81%) 
Metabolism and nutrition disorders     
Decreased appetite  1  35/173 (20.23%)  7/86 (8.14%) 
Dehydration  1  14/173 (8.09%)  0/86 (0.00%) 
Hyperglycaemia  1  15/173 (8.67%)  1/86 (1.16%) 
Hypokalaemia  1  30/173 (17.34%)  4/86 (4.65%) 
Hypomagnesaemia  1  11/173 (6.36%)  3/86 (3.49%) 
Hyponatraemia  1  11/173 (6.36%)  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  18/173 (10.40%)  5/86 (5.81%) 
Back pain  1  24/173 (13.87%)  11/86 (12.79%) 
Muscle spasms  1  18/173 (10.40%)  2/86 (2.33%) 
Musculoskeletal pain  1  12/173 (6.94%)  1/86 (1.16%) 
Myalgia  1  13/173 (7.51%)  1/86 (1.16%) 
Pain in extremity  1  19/173 (10.98%)  5/86 (5.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  9/173 (5.20%)  3/86 (3.49%) 
Nervous system disorders     
Dizziness  1  16/173 (9.25%)  5/86 (5.81%) 
Dysgeusia  1  11/173 (6.36%)  3/86 (3.49%) 
Headache  1  36/173 (20.81%)  9/86 (10.47%) 
Hypoaesthesia  1  10/173 (5.78%)  1/86 (1.16%) 
Neuropathy peripheral  1  11/173 (6.36%)  6/86 (6.98%) 
Paraesthesia  1  11/173 (6.36%)  4/86 (4.65%) 
Peripheral sensory neuropathy  1  6/173 (3.47%)  5/86 (5.81%) 
Psychiatric disorders     
Anxiety  1  14/173 (8.09%)  2/86 (2.33%) 
Confusional state  1  10/173 (5.78%)  0/86 (0.00%) 
Insomnia  1  30/173 (17.34%)  12/86 (13.95%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  58/173 (33.53%)  18/86 (20.93%) 
Dysphonia  1  9/173 (5.20%)  1/86 (1.16%) 
Dyspnoea  1  33/173 (19.08%)  11/86 (12.79%) 
Epistaxis  1  8/173 (4.62%)  6/86 (6.98%) 
Nasal congestion  1  11/173 (6.36%)  6/86 (6.98%) 
Oropharyngeal pain  1  17/173 (9.83%)  3/86 (3.49%) 
Productive cough  1  16/173 (9.25%)  0/86 (0.00%) 
Rhinorrhoea  1  12/173 (6.94%)  1/86 (1.16%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  9/173 (5.20%)  1/86 (1.16%) 
Night sweats  1  11/173 (6.36%)  10/86 (11.63%) 
Pruritus  1  21/173 (12.14%)  6/86 (6.98%) 
Rash  1  35/173 (20.23%)  7/86 (8.14%) 
Rash maculo-papular  1  12/173 (6.94%)  0/86 (0.00%) 
Vascular disorders     
Hypertension  1  21/173 (12.14%)  6/86 (6.98%) 
Hypotension  1  13/173 (7.51%)  5/86 (5.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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: NCT01659021     History of Changes
Other Study ID Numbers: GS-US-312-0119
2012-001236-65 ( EudraCT Number )
First Submitted: August 3, 2012
First Posted: August 7, 2012
Results First Submitted: February 14, 2017
Results First Posted: March 31, 2017
Last Update Posted: November 19, 2018