Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659021
Recruitment Status : Terminated
First Posted : August 7, 2012
Results First Posted : March 31, 2017
Last Update Posted : August 14, 2019
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 occurred on 15 August 2018.
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

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

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

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

Period Title: Main Study
Started 174 87
Randomized and Treated 173 86
Completed [1] 100 50
Not Completed 74 37
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             1             0
Unknown Reasons             2             1
Physician Decision             34             16
Withdrawal by Subject             19             16
Study Terminated by Sponsor             16             1
[1]
Study completion was defined as disease progression or death.
Period Title: Long-Term Follow Up
Started 138 [1] 69 [1]
Completed 133 65
Not Completed 5 4
Reason Not Completed
Lost to Follow-up             3             3
Withdrawal by Subject             2             1
[1]
Participants did not have to complete the main study to enter the Long-Term Follow Up period.
Arm/Group Title Idelalisib+Ofatumumab Ofatumumab Total
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

Total of all reporting groups
Overall Number of Baseline Participants 174 87 261
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Analysis Set included participants who were randomized in the study regardless of whether they received any study drug(s), or received a different regimen from that to which they were randomized. Treatment assignment was designated according to 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 25 75
Male 124 62 186
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 87 participants 261 participants
Hispanic or Latino 7 3 10
Not Hispanic or Latino 141 74 215
Unknown or Not Reported 26 10 36
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 87 participants 261 participants
White 149 71 220
Black or African American 0 4 4
Native Hawaiian or Other Pacific Islander 1 0 1
Asian 2 0 2
Other 2 3 5
Not Permitted 20 9 29
Region of Enrollment  
Measure Type: Count of Participants
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
Number Analyzed 174 participants 87 participants 261 participants
Either 70 33 103
Neither 104 54 158
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 19 56
Unmutated 137 68 205
Disease Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 87 participants 261 participants
Refractory 82 47 129
Relapsed 92 40 132
[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 (PFS) 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. PFS was analyzed using Kaplan-Meier (KM) estimates.
Time Frame Randomization to End of Study (up to 60 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Analysis Set included participants who were randomized in the study regardless of whether they received any study drug(s), or received a different regimen from that to which they were randomized. Treatment assignment was designated according to 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
(13.7 to 19.6)
8.0
(5.7 to 8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Idelalisib+Ofatumumab, Ofatumumab
Comments [Not Specified]
Type of Statistical Test Superiority
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, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
0.18 to 0.37
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. Overall response rate was analyzed using KM estimates.
Time Frame Randomization to End of Study (up to 60 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set 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 174 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.3
(68.2 to 81.5)
17.2
(10.0 to 26.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Idelalisib+Ofatumumab, Ofatumumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated from the Cochran-Mantel-Haenszel (CMH) Chi-square test stratified by stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 16.85
Confidence Interval (2-Sided) 95%
8.17 to 34.76
Estimation Comments Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.
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 Randomization to End of Study (up to 60 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Idelalisib+Ofatumumab, Ofatumumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was calculated from the CMH Chi-square test stratified by stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 483.16
Confidence Interval (2-Sided) 95%
94.63 to 2467.02
Estimation Comments Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
Time Frame Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set 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

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

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

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

Overall Number of Participants Analyzed 174 87
Median (95% Confidence Interval)
Unit of Measure: months
45.2 [1] 
(34.1 to NA)
39 [1] 
(23.0 to NA)
[1]
NA = Too few events to estimate the upper limit of the confidence interval.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Idelalisib+Ofatumumab, Ofatumumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
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 0.79
Confidence Interval (2-Sided) 95%
0.54 to 1.15
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
Hide Description Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
Time Frame Randomization to End of Study (up to 60 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
16.2
(11.1 to 19.1)
5.8
(4.5 to 8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Idelalisib+Ofatumumab, Ofatumumab
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.17 to 0.51
Estimation Comments Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model without any adjustments.
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 Randomization to End of Study (up to 60 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set 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 174 87
Measure Type: Number
Unit of Measure: percentage of participants
1.1 0
Time Frame Adverse Events: Start of Treatment to End of Treatment (up to 60 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Adverse Event Reporting Description All-Cause Mortality was assessed in all randomized participants. All other adverse events were assessed in the 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

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

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

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

All-Cause Mortality
Idelalisib+Ofatumumab Ofatumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   87/174 (50.00%)   40/87 (45.98%) 
Hide Serious Adverse Events
Idelalisib+Ofatumumab Ofatumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   136/173 (78.61%)   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  13/173 (7.51%)  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%) 
Aortic valve disease  1  1/173 (0.58%)  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  23/173 (13.29%)  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%) 
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%) 
Chronic sinusitis  1  1/173 (0.58%)  0/86 (0.00%) 
Cytomegalovirus colitis  1  1/173 (0.58%)  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%) 
Influenza  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  7/173 (4.05%)  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  27/173 (15.61%)  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%) 
Respiratory tract infection bacterial  1  1/173 (0.58%)  0/86 (0.00%) 
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%) 
Vascular device infection  1  1/173 (0.58%)  0/86 (0.00%) 
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  3/173 (1.73%)  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%) 
C-reactive protein 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  3/173 (1.73%)  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%) 
Central nervous system leukaemia  1  0/173 (0.00%)  1/86 (1.16%) 
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%) 
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%) 
Chronic kidney disease  1  1/173 (0.58%)  0/86 (0.00%) 
Haematuria  1  2/173 (1.16%)  0/86 (0.00%) 
Renal failure  1  3/173 (1.73%)  0/86 (0.00%) 
Urinary retention  1  1/173 (0.58%)  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%) 
Lung disorder  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%) 
Peripheral artery aneurysm  1  1/173 (0.58%)  0/86 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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  38/173 (21.97%)  7/86 (8.14%) 
Neutropenia  1  57/173 (32.95%)  14/86 (16.28%) 
Thrombocytopenia  1  25/173 (14.45%)  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  15/173 (8.67%)  4/86 (4.65%) 
Colitis  1  17/173 (9.83%)  0/86 (0.00%) 
Constipation  1  39/173 (22.54%)  13/86 (15.12%) 
Diarrhoea  1  96/173 (55.49%)  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  62/173 (35.84%)  23/86 (26.74%) 
Stomatitis  1  9/173 (5.20%)  0/86 (0.00%) 
Vomiting  1  29/173 (16.76%)  12/86 (13.95%) 
General disorders     
Asthenia  1  27/173 (15.61%)  9/86 (10.47%) 
Chest pain  1  9/173 (5.20%)  2/86 (2.33%) 
Chills  1  27/173 (15.61%)  13/86 (15.12%) 
Fatigue  1  60/173 (34.68%)  24/86 (27.91%) 
Influenza like illness  1  14/173 (8.09%)  1/86 (1.16%) 
Malaise  1  10/173 (5.78%)  1/86 (1.16%) 
Oedema peripheral  1  35/173 (20.23%)  9/86 (10.47%) 
Pain  1  13/173 (7.51%)  2/86 (2.33%) 
Peripheral swelling  1  12/173 (6.94%)  1/86 (1.16%) 
Pyrexia  1  55/173 (31.79%)  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  21/173 (12.14%)  2/86 (2.33%) 
Respiratory tract infection  1  9/173 (5.20%)  1/86 (1.16%) 
Sinusitis  1  23/173 (13.29%)  3/86 (3.49%) 
Upper respiratory tract infection  1  47/173 (27.17%)  9/86 (10.47%) 
Urinary tract infection  1  18/173 (10.40%)  6/86 (6.98%) 
Injury, poisoning and procedural complications     
Contusion  1  18/173 (10.40%)  3/86 (3.49%) 
Infusion related reaction  1  30/173 (17.34%)  23/86 (26.74%) 
Investigations     
Alanine aminotransferase increased  1  19/173 (10.98%)  2/86 (2.33%) 
Aspartate aminotransferase increased  1  14/173 (8.09%)  2/86 (2.33%) 
Neutrophil count decreased  1  16/173 (9.25%)  2/86 (2.33%) 
Platelet count decreased  1  9/173 (5.20%)  1/86 (1.16%) 
Weight decreased  1  28/173 (16.18%)  5/86 (5.81%) 
Metabolism and nutrition disorders     
Decreased appetite  1  37/173 (21.39%)  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  32/173 (18.50%)  4/86 (4.65%) 
Hypomagnesaemia  1  11/173 (6.36%)  3/86 (3.49%) 
Hyponatraemia  1  12/173 (6.94%)  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/173 (10.98%)  5/86 (5.81%) 
Back pain  1  28/173 (16.18%)  11/86 (12.79%) 
Muscle spasms  1  18/173 (10.40%)  2/86 (2.33%) 
Musculoskeletal pain  1  13/173 (7.51%)  1/86 (1.16%) 
Myalgia  1  15/173 (8.67%)  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  11/173 (6.36%)  3/86 (3.49%) 
Nervous system disorders     
Dizziness  1  17/173 (9.83%)  5/86 (5.81%) 
Dysgeusia  1  11/173 (6.36%)  3/86 (3.49%) 
Headache  1  37/173 (21.39%)  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  15/173 (8.67%)  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  60/173 (34.68%)  18/86 (20.93%) 
Dysphonia  1  9/173 (5.20%)  1/86 (1.16%) 
Dyspnoea  1  34/173 (19.65%)  11/86 (12.79%) 
Epistaxis  1  9/173 (5.20%)  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  17/173 (9.83%)  0/86 (0.00%) 
Rhinorrhoea  1  12/173 (6.94%)  1/86 (1.16%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  11/173 (6.36%)  1/86 (1.16%) 
Night sweats  1  17/173 (9.83%)  10/86 (11.63%) 
Pruritus  1  21/173 (12.14%)  6/86 (6.98%) 
Rash  1  36/173 (20.81%)  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  14/173 (8.09%)  5/86 (5.81%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.
Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.
Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark.
Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria.
Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01659021    
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: August 14, 2019