Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela ) (Tugela)

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ClinicalTrials.gov Identifier: NCT01569295

Recruitment Status : Completed

First Posted : April 3, 2012

Results First Posted : February 27, 2018

Last Update Posted : March 10, 2020

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Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Chronic Lymphocytic Leukemia
Interventions	Drug: Idelalisib Drug: Rituximab Drug: Bendamustine Drug: Placebo to match idelalisib
Enrollment	416

Participant Flow

Recruitment Details	Participants were enrolled at a total of 110 sites in Australia, New Zealand, Europe, Asia and North America. The first participant was screened on 15 June 2012. The last study visit occurred on 10 June 2019.
Pre-assignment Details	540 participants were screened.


Arm/Group Title	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...
Arm/Group Description	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
Period Title: Overall Study
Started	207	209
Long-Term Follow-up	109	161
Completed	0	0
Not Completed	207	209
Reason Not Completed
Progressive Disease	75	139
Adverse Event	39	14
Withdrawal by Subject	25	12
Death	19	15
Physician Decision	13	18
Study Terminated by Sponsor	24	2
Other Reason not Specified	3	5
Non-Compliance with Study Drug	6	1
Other Anticancer/Experimental Therapy	2	2
Lost to Follow-up	1	1

Baseline Characteristics

Arm/Group Title		Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab	Total
Arm/Group Description		Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...	Total of all reporting groups
Arm/Group Description		Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).	Total of all reporting groups
Overall Number of Baseline Participants		207	209	416
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The intent-to-treat (ITT) Analysis Set included all participants randomized in the study regardless of whether study drug was administered and with treatment group designated according to initial randomization.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	207 participants	209 participants	416 participants
		62 (9.2)	63 (9.8)	62 (9.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	207 participants	209 participants	416 participants
	Female	47 22.7%	53 25.4%	100 24.0%
	Male	160 77.3%	156 74.6%	316 76.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
Race	Number Analyzed	207 participants	209 participants	416 participants
	White	187 90.3%	190 90.9%	377 90.6%
	Black or African American	6 2.9%	4 1.9%	10 2.4%
	Asian	2 1.0%	1 0.5%	3 0.7%
	Other	2 1.0%	2 1.0%	4 1.0%
	Not Permitted	10 4.8%	12 5.7%	22 5.3%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
Ethnicity	Number Analyzed	207 participants	209 participants	416 participants
	Hispanic or Latino	4 1.9%	5 2.4%	9 2.2%
	Not Hispanic or Latino	191 92.3%	188 90.0%	379 91.1%
	Not Permitted	12 5.8%	15 7.2%	27 6.5%
	Missing	0 0.0%	1 0.5%	1 0.2%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	207 participants	209 participants	416 participants
Romania		5 2.4%	6 2.9%	11 2.6%
Hungary		24 11.6%	20 9.6%	44 10.6%
United States		37 17.9%	33 15.8%	70 16.8%
Czechia		9 4.3%	5 2.4%	14 3.4%
United Kingdom		27 13.0%	29 13.9%	56 13.5%
Portugal		1 0.5%	4 1.9%	5 1.2%
Russia		22 10.6%	14 6.7%	36 8.7%
Spain		14 6.8%	18 8.6%	32 7.7%
Greece		1 0.5%	1 0.5%	2 0.5%
Canada		0 0.0%	3 1.4%	3 0.7%
Turkey		6 2.9%	6 2.9%	12 2.9%
Belgium		3 1.4%	7 3.3%	10 2.4%
Ireland		1 0.5%	1 0.5%	2 0.5%
Poland		17 8.2%	22 10.5%	39 9.4%
Italy		10 4.8%	7 3.3%	17 4.1%
Australia		8 3.9%	8 3.8%	16 3.8%
France		13 6.3%	14 6.7%	27 6.5%
Croatia		5 2.4%	9 4.3%	14 3.4%
New Zealand		4 1.9%	2 1.0%	6 1.4%

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival (PFS)
Description	PFS was defined as the interval from randomization to the earlier of t...
Description	PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
Time Frame	Up to 84 months

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) Analysis Set included all participants randomised in the study regardless of whether study drug was administered and with treatment group designated according to initial randomisation.


Arm/Group Title	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
Arm/Group Description:	Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...
Arm/Group Description:	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
Overall Number of Participants Analyzed	207	209
Median (95% Confidence Interval) Unit of Measure: months
	21.8 (16.5 to 27.8)	11.1 (8.9 to 11.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idelalisib + Bendamustine + Rituximab, Placebo + Bendamustine + Rituximab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95% 0.27 to 0.45
	Estimation Comments	Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.

2.Secondary Outcome


Title	Overall Response Rate (ORR)
Description	ORR was the percentage of participants who achieved a complete respons...
Description	ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy. PR 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. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.
Time Frame	Up to 84 months

Outcome Measure Data

Analysis Population Description

Participants in the ITT Analysis Set were analyzed.


Arm/Group Title	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
Arm/Group Description:	Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...
Arm/Group Description:	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
Overall Number of Participants Analyzed	207	209
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	70.0 (63.3 to 76.2)	45.5 (38.6 to 52.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idelalisib + Bendamustine + Rituximab, Placebo + Bendamustine + Rituximab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Odds ratio,p-value and 95% Confidence Interval(CI) were calculated from Cochran-Mantel-Haenszel(CMH) Chi-square test stratified by stratification factor in EDC(del17p/TP53,immunoglobulin heavy chain variable region(IgHV) mutation and disease status).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.02
	Confidence Interval	(2-Sided) 95% 1.98 to 4.62
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Lymph Node Response Rate
Description	Lymph node response rate was defined as the percentage of participants...
Description	Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
Time Frame	Up to 84 months

Outcome Measure Data

Analysis Population Description

Participants in the ITT Analysis Set with available data were analyzed.


Arm/Group Title	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
Arm/Group Description:	Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...
Arm/Group Description:	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
Overall Number of Participants Analyzed	192	197
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of particpants
	96.9 (93.3 to 98.8)	60.9 (53.7 to 67.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idelalisib + Bendamustine + Rituximab, Placebo + Bendamustine + Rituximab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Odds ratio, p-value and 95% CI were calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	28.81
	Confidence Interval	(2-Sided) 95% 10.50 to 79.02
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Overall Survival
Description	Overall survival (OS) was defined as the interval from randomization t...
Description	Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
Time Frame	Up to 84 months

Outcome Measure Data

Analysis Population Description

Participants in the ITT Analysis Set were analyzed.


Arm/Group Title	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
Arm/Group Description:	Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...
Arm/Group Description:	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
Overall Number of Participants Analyzed	207	209
Median (95% Confidence Interval) Unit of Measure: months
	56.2 ^[1] (40.1 to NA)	42.6 (35.3 to 54.8)

[1]

Upper CI was not reached due to the low number of deaths by the time of study closure.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idelalisib + Bendamustine + Rituximab, Placebo + Bendamustine + Rituximab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.098
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95% 0.59 to 1.03
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Complete Response Rate
Description	Complete response (CR) rate was defined as the percentage of participa...
Description	Complete response (CR) rate was defined as the percentage of participants who achieved a CR.
Time Frame	Up to 84 months

Outcome Measure Data

Analysis Population Description

Participants in the ITT Analysis Set were analyzed.


Arm/Group Title	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
Arm/Group Description:	Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...
Arm/Group Description:	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
Overall Number of Participants Analyzed	207	209
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	4.3 (2.0 to 8.1)	0.5 (0 to 2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idelalisib + Bendamustine + Rituximab, Placebo + Bendamustine + Rituximab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.011
	Comments	Odds ratio, 95% CI and p-value are calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9.55
	Confidence Interval	(2-Sided) 95% 1.19 to 76.81
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	First dose up to the last dose date plus 30 days (Up to approximately 67.7 months)
Adverse Event Reporting Description	The Safety Analysis Set included all participants who received >=1 dose of study treatment, with treatment group assignments designated according to the actual treatment received.

Arm/Group Title	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet administer...	Placebo to match idelalisib adminis...
Arm/Group Description	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
All-Cause Mortality
	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	89/207 (43.00%)	106/209 (50.72%)
Serious Adverse Events Serious Adverse Events
	Idelalisib + Bendamustine + Rituximab	Placebo + Bendamustine + Rituximab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	152/207 (73.43%)	94/209 (44.98%)
Blood and lymphatic system disorders
Agranulocytosis ^† 1	0/207 (0.00%)	2/209 (0.96%)
Anaemia ^† 1	8/207 (3.86%)	5/209 (2.39%)
Autoimmune haemolytic anaemia ^† 1	0/207 (0.00%)	2/209 (0.96%)
Febrile neutropenia ^† 1	45/207 (21.74%)	10/209 (4.78%)
Haemolytic anaemia ^† 1	0/207 (0.00%)	1/209 (0.48%)
Immune thrombocytopenic purpura ^† 1	1/207 (0.48%)	1/209 (0.48%)
Lymphadenopathy ^† 1	0/207 (0.00%)	1/209 (0.48%)
Neutropenia ^† 1	9/207 (4.35%)	3/209 (1.44%)
Pancytopenia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Thrombocytopenia ^† 1	4/207 (1.93%)	0/209 (0.00%)
Thrombotic thrombocytopenic purpura ^† 1	0/207 (0.00%)	1/209 (0.48%)
Cardiac disorders
Acute myocardial infarction ^† 1	0/207 (0.00%)	2/209 (0.96%)
Angina pectoris ^† 1	1/207 (0.48%)	0/209 (0.00%)
Atrial fibrillation ^† 1	1/207 (0.48%)	1/209 (0.48%)
Cardiac arrest ^† 1	1/207 (0.48%)	1/209 (0.48%)
Cardiac failure ^† 1	0/207 (0.00%)	1/209 (0.48%)
Cardiac failure congestive ^† 1	1/207 (0.48%)	0/209 (0.00%)
Left ventricular dysfunction ^† 1	1/207 (0.48%)	0/209 (0.00%)
Pericardial effusion ^† 1	1/207 (0.48%)	0/209 (0.00%)
Supraventricular extrasystoles ^† 1	1/207 (0.48%)	0/209 (0.00%)
Eye disorders
Rhegmatogenous retinal detachment ^† 1	1/207 (0.48%)	0/209 (0.00%)
Vision blurred ^† 1	0/207 (0.00%)	1/209 (0.48%)
Gastrointestinal disorders
Abdominal hernia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Abdominal pain ^† 1	4/207 (1.93%)	2/209 (0.96%)
Ascites ^† 1	0/207 (0.00%)	2/209 (0.96%)
Colitis ^† 1	5/207 (2.42%)	1/209 (0.48%)
Colitis microscopic ^† 1	1/207 (0.48%)	0/209 (0.00%)
Colitis ulcerative ^† 1	1/207 (0.48%)	0/209 (0.00%)
Constipation ^† 1	1/207 (0.48%)	0/209 (0.00%)
Diarrhoea ^† 1	14/207 (6.76%)	1/209 (0.48%)
Enterovesical fistula ^† 1	1/207 (0.48%)	0/209 (0.00%)
Gastric haemorrhage ^† 1	1/207 (0.48%)	1/209 (0.48%)
Gastrointestinal haemorrhage ^† 1	1/207 (0.48%)	0/209 (0.00%)
Intestinal perforation ^† 1	1/207 (0.48%)	0/209 (0.00%)
Nausea ^† 1	1/207 (0.48%)	2/209 (0.96%)
Neutropenic colitis ^† 1	0/207 (0.00%)	1/209 (0.48%)
Pancreatitis ^† 1	2/207 (0.97%)	0/209 (0.00%)
Pancreatitis acute ^† 1	1/207 (0.48%)	0/209 (0.00%)
Pneumatosis intestinalis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Pneumoperitoneum ^† 1	1/207 (0.48%)	0/209 (0.00%)
Vomiting ^† 1	0/207 (0.00%)	2/209 (0.96%)
General disorders
Asthenia ^† 1	1/207 (0.48%)	2/209 (0.96%)
Chest pain ^† 1	0/207 (0.00%)	1/209 (0.48%)
Chills ^† 1	2/207 (0.97%)	0/209 (0.00%)
Fatigue ^† 1	2/207 (0.97%)	2/209 (0.96%)
General physical health deterioration ^† 1	1/207 (0.48%)	1/209 (0.48%)
Malaise ^† 1	1/207 (0.48%)	0/209 (0.00%)
Multiple organ dysfunction syndrome ^† 1	1/207 (0.48%)	1/209 (0.48%)
Pyrexia ^† 1	25/207 (12.08%)	11/209 (5.26%)
Hepatobiliary disorders
Bile duct obstruction ^† 1	0/207 (0.00%)	1/209 (0.48%)
Biliary fistula ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cholangitis ^† 1	0/207 (0.00%)	1/209 (0.48%)
Cholecystitis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cholelithiasis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Hepatic failure ^† 1	0/207 (0.00%)	1/209 (0.48%)
Hepatitis toxic ^† 1	1/207 (0.48%)	0/209 (0.00%)
Hepatocellular injury ^† 1	2/207 (0.97%)	0/209 (0.00%)
Hepatotoxicity ^† 1	0/207 (0.00%)	1/209 (0.48%)
Immune system disorders
Drug hypersensitivity ^† 1	1/207 (0.48%)	0/209 (0.00%)
Haemophagocytic lymphohistiocytosis ^† 1	0/207 (0.00%)	1/209 (0.48%)
Hypersensitivity ^† 1	2/207 (0.97%)	0/209 (0.00%)
Infections and infestations
Aspergillus infection ^† 1	0/207 (0.00%)	1/209 (0.48%)
Bacteraemia ^† 1	0/207 (0.00%)	1/209 (0.48%)
Bacterial sepsis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Brain abscess ^† 1	0/207 (0.00%)	1/209 (0.48%)
Bronchitis ^† 1	1/207 (0.48%)	5/209 (2.39%)
Bronchopulmonary aspergillosis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Campylobacter gastroenteritis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cellulitis ^† 1	4/207 (1.93%)	0/209 (0.00%)
Clostridium difficile infection ^† 1	0/207 (0.00%)	1/209 (0.48%)
Conjunctivitis bacterial ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cystitis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cytomegalovirus chorioretinitis ^† 1	1/207 (0.48%)	1/209 (0.48%)
Cytomegalovirus colitis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cytomegalovirus enteritis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cytomegalovirus infection ^† 1	3/207 (1.45%)	1/209 (0.48%)
Cytomegalovirus viraemia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Device related infection ^† 1	2/207 (0.97%)	1/209 (0.48%)
Diverticulitis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Ecthyma ^† 1	1/207 (0.48%)	0/209 (0.00%)
Escherichia bacteraemia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Escherichia sepsis ^† 1	2/207 (0.97%)	0/209 (0.00%)
Eye infection toxoplasmal ^† 1	1/207 (0.48%)	0/209 (0.00%)
Fungal infection ^† 1	0/207 (0.00%)	1/209 (0.48%)
Gastroenteritis ^† 1	2/207 (0.97%)	0/209 (0.00%)
Gastroenteritis cryptosporidial ^† 1	1/207 (0.48%)	0/209 (0.00%)
H1n1 influenza ^† 1	1/207 (0.48%)	0/209 (0.00%)
Haemophilus infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Herpes simplex ^† 1	1/207 (0.48%)	0/209 (0.00%)
Herpes zoster ^† 1	4/207 (1.93%)	1/209 (0.48%)
Human herpesvirus 6 infection ^† 1	0/207 (0.00%)	1/209 (0.48%)
Impetigo ^† 1	0/207 (0.00%)	1/209 (0.48%)
Influenza ^† 1	3/207 (1.45%)	1/209 (0.48%)
Lower respiratory tract infection ^† 1	7/207 (3.38%)	5/209 (2.39%)
Lower respiratory tract infection fungal ^† 1	1/207 (0.48%)	0/209 (0.00%)
Lung infection ^† 1	0/207 (0.00%)	3/209 (1.44%)
Meningitis aseptic ^† 1	1/207 (0.48%)	0/209 (0.00%)
Meningitis bacterial ^† 1	0/207 (0.00%)	1/209 (0.48%)
Meningitis enteroviral ^† 1	1/207 (0.48%)	0/209 (0.00%)
Neutropenic infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Neutropenic sepsis ^† 1	3/207 (1.45%)	6/209 (2.87%)
Ophthalmic herpes zoster ^† 1	2/207 (0.97%)	0/209 (0.00%)
Oral herpes ^† 1	1/207 (0.48%)	0/209 (0.00%)
Oropharyngitis fungal ^† 1	1/207 (0.48%)	0/209 (0.00%)
Otitis externa ^† 1	1/207 (0.48%)	0/209 (0.00%)
Otitis media ^† 1	0/207 (0.00%)	2/209 (0.96%)
Perineal infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Pharyngeal abscess ^† 1	0/207 (0.00%)	1/209 (0.48%)
Pneumocystis jirovecii infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Pneumocystis jirovecii pneumonia ^† 1	3/207 (1.45%)	0/209 (0.00%)
Pneumonia ^† 1	38/207 (18.36%)	16/209 (7.66%)
Pneumonia bacterial ^† 1	0/207 (0.00%)	1/209 (0.48%)
Pneumonia cytomegaloviral ^† 1	1/207 (0.48%)	1/209 (0.48%)
Pneumonia pseudomonal ^† 1	2/207 (0.97%)	0/209 (0.00%)
Pneumonia viral ^† 1	0/207 (0.00%)	1/209 (0.48%)
Pulmonary mycosis ^† 1	0/207 (0.00%)	1/209 (0.48%)
Pulmonary sepsis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Respiratory syncytial virus infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Respiratory tract infection ^† 1	5/207 (2.42%)	5/209 (2.39%)
Rhinovirus infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Sepsis ^† 1	11/207 (5.31%)	4/209 (1.91%)
Septic shock ^† 1	5/207 (2.42%)	1/209 (0.48%)
Sinusitis ^† 1	2/207 (0.97%)	0/209 (0.00%)
Skin infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Soft tissue infection ^† 1	1/207 (0.48%)	0/209 (0.00%)
Tonsillitis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Tuberculosis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Upper respiratory tract infection ^† 1	1/207 (0.48%)	4/209 (1.91%)
Upper respiratory tract infection bacterial ^† 1	1/207 (0.48%)	0/209 (0.00%)
Urinary tract infection ^† 1	7/207 (3.38%)	3/209 (1.44%)
Urinary tract infection bacterial ^† 1	0/207 (0.00%)	1/209 (0.48%)
Urosepsis ^† 1	2/207 (0.97%)	1/209 (0.48%)
Viral infection ^† 1	0/207 (0.00%)	1/209 (0.48%)
Injury, poisoning and procedural complications
Ankle fracture ^† 1	1/207 (0.48%)	0/209 (0.00%)
Cervical vertebral fracture ^† 1	1/207 (0.48%)	0/209 (0.00%)
Eye injury ^† 1	0/207 (0.00%)	1/209 (0.48%)
Femur fracture ^† 1	1/207 (0.48%)	1/209 (0.48%)
Infusion related reaction ^† 1	1/207 (0.48%)	3/209 (1.44%)
Periprosthetic fracture ^† 1	1/207 (0.48%)	0/209 (0.00%)
Wrist fracture ^† 1	1/207 (0.48%)	0/209 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	1/207 (0.48%)	0/209 (0.00%)
Anticoagulation drug level above therapeutic ^† 1	1/207 (0.48%)	0/209 (0.00%)
Aspartate aminotransferase increased ^† 1	1/207 (0.48%)	0/209 (0.00%)
Bk polyomavirus test positive ^† 1	1/207 (0.48%)	0/209 (0.00%)
Blood creatinine increased ^† 1	1/207 (0.48%)	0/209 (0.00%)
Blood lactate dehydrogenase increased ^† 1	0/207 (0.00%)	1/209 (0.48%)
Neutrophil count decreased ^† 1	1/207 (0.48%)	0/209 (0.00%)
Streptococcus test positive ^† 1	1/207 (0.48%)	0/209 (0.00%)
Transaminases increased ^† 1	1/207 (0.48%)	0/209 (0.00%)
Metabolism and nutrition disorders
Cachexia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Decreased appetite ^† 1	1/207 (0.48%)	0/209 (0.00%)
Dehydration ^† 1	1/207 (0.48%)	1/209 (0.48%)
Diabetes mellitus inadequate control ^† 1	1/207 (0.48%)	0/209 (0.00%)
Hypercalcaemia ^† 1	0/207 (0.00%)	1/209 (0.48%)
Hyperglycaemia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Hypoalbuminaemia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Hypokalaemia ^† 1	1/207 (0.48%)	1/209 (0.48%)
Hyponatraemia ^† 1	2/207 (0.97%)	0/209 (0.00%)
Hypovolaemia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Malnutrition ^† 1	1/207 (0.48%)	0/209 (0.00%)
Tumour lysis syndrome ^† 1	3/207 (1.45%)	2/209 (0.96%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Chondritis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Chondrocalcinosis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Myalgia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Polyarthritis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Reiter's syndrome ^† 1	1/207 (0.48%)	0/209 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Adenocarcinoma of colon ^† 1	0/207 (0.00%)	2/209 (0.96%)
Basal cell carcinoma ^† 1	3/207 (1.45%)	0/209 (0.00%)
Bladder cancer ^† 1	1/207 (0.48%)	0/209 (0.00%)
Bowen's disease ^† 1	1/207 (0.48%)	0/209 (0.00%)
Chronic lymphocytic leukaemia ^† 1	1/207 (0.48%)	0/209 (0.00%)
Gastric cancer ^† 1	0/207 (0.00%)	1/209 (0.48%)
Leiomyosarcoma ^† 1	1/207 (0.48%)	0/209 (0.00%)
Lip squamous cell carcinoma ^† 1	1/207 (0.48%)	0/209 (0.00%)
Lung adenocarcinoma ^† 1	1/207 (0.48%)	1/209 (0.48%)
Lung neoplasm malignant ^† 1	1/207 (0.48%)	0/209 (0.00%)
Malignant melanoma ^† 1	2/207 (0.97%)	0/209 (0.00%)
Meningioma ^† 1	1/207 (0.48%)	0/209 (0.00%)
Metastases to bone ^† 1	1/207 (0.48%)	0/209 (0.00%)
Myelodysplastic syndrome ^† 1	4/207 (1.93%)	0/209 (0.00%)
Nasopharyngeal cancer ^† 1	0/207 (0.00%)	1/209 (0.48%)
Oesophageal carcinoma ^† 1	1/207 (0.48%)	0/209 (0.00%)
Prostate cancer ^† 1	2/207 (0.97%)	0/209 (0.00%)
Rectal adenocarcinoma ^† 1	1/207 (0.48%)	0/209 (0.00%)
Salivary gland neoplasm ^† 1	1/207 (0.48%)	0/209 (0.00%)
Squamous cell carcinoma ^† 1	1/207 (0.48%)	5/209 (2.39%)
Squamous cell carcinoma of lung ^† 1	1/207 (0.48%)	0/209 (0.00%)
Squamous cell carcinoma of skin ^† 1	3/207 (1.45%)	2/209 (0.96%)
T-cell lymphoma ^† 1	0/207 (0.00%)	1/209 (0.48%)
Transitional cell carcinoma ^† 1	1/207 (0.48%)	0/209 (0.00%)
Nervous system disorders
Cerebral haemorrhage ^† 1	1/207 (0.48%)	0/209 (0.00%)
Dizziness ^† 1	1/207 (0.48%)	0/209 (0.00%)
Headache ^† 1	0/207 (0.00%)	1/209 (0.48%)
Ischaemic stroke ^† 1	1/207 (0.48%)	0/209 (0.00%)
Post herpetic neuralgia ^† 1	0/207 (0.00%)	1/209 (0.48%)
Seizure ^† 1	1/207 (0.48%)	0/209 (0.00%)
Syncope ^† 1	1/207 (0.48%)	0/209 (0.00%)
Psychiatric disorders
Anxiety ^† 1	0/207 (0.00%)	1/209 (0.48%)
Confusional state ^† 1	1/207 (0.48%)	0/209 (0.00%)
Delusion ^† 1	1/207 (0.48%)	0/209 (0.00%)
Mental status changes ^† 1	0/207 (0.00%)	1/209 (0.48%)
Mood swings ^† 1	1/207 (0.48%)	0/209 (0.00%)
Panic attack ^† 1	1/207 (0.48%)	0/209 (0.00%)
Personality change ^† 1	1/207 (0.48%)	0/209 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/207 (0.48%)	1/209 (0.48%)
Calculus urinary ^† 1	0/207 (0.00%)	1/209 (0.48%)
Haematuria ^† 1	1/207 (0.48%)	0/209 (0.00%)
Renal colic ^† 1	2/207 (0.97%)	0/209 (0.00%)
Renal failure ^† 1	0/207 (0.00%)	1/209 (0.48%)
Urinary incontinence ^† 1	1/207 (0.48%)	0/209 (0.00%)
Reproductive system and breast disorders
Cervical polyp ^† 1	1/207 (0.48%)	0/209 (0.00%)
Perineal necrosis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^† 1	0/207 (0.00%)	1/209 (0.48%)
Bronchial hyperreactivity ^† 1	1/207 (0.48%)	0/209 (0.00%)
Chronic obstructive pulmonary disease ^† 1	0/207 (0.00%)	1/209 (0.48%)
Cough ^† 1	4/207 (1.93%)	2/209 (0.96%)
Dyspnoea ^† 1	4/207 (1.93%)	3/209 (1.44%)
Epistaxis ^† 1	0/207 (0.00%)	1/209 (0.48%)
Hypoxia ^† 1	2/207 (0.97%)	0/209 (0.00%)
Lung disorder ^† 1	0/207 (0.00%)	1/209 (0.48%)
Pleural effusion ^† 1	3/207 (1.45%)	0/209 (0.00%)
Pneumonia aspiration ^† 1	1/207 (0.48%)	0/209 (0.00%)
Pneumonitis ^† 1	4/207 (1.93%)	0/209 (0.00%)
Pneumothorax ^† 1	0/207 (0.00%)	1/209 (0.48%)
Pulmonary embolism ^† 1	2/207 (0.97%)	5/209 (2.39%)
Pulmonary pain ^† 1	0/207 (0.00%)	1/209 (0.48%)
Respiratory distress ^† 1	1/207 (0.48%)	0/209 (0.00%)
Respiratory failure ^† 1	2/207 (0.97%)	0/209 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis atopic ^† 1	1/207 (0.48%)	0/209 (0.00%)
Dermatitis exfoliative ^† 1	1/207 (0.48%)	0/209 (0.00%)
Dermatitis exfoliative generalised ^† 1	1/207 (0.48%)	0/209 (0.00%)
Drug reaction with eosinophilia and systemic symptoms ^† 1	1/207 (0.48%)	0/209 (0.00%)
Rash macular ^† 1	1/207 (0.48%)	0/209 (0.00%)
Rash maculo-papular ^† 1	1/207 (0.48%)	0/209 (0.00%)
Stevens-Johnson syndrome ^† 1	2/207 (0.97%)	0/209 (0.00%)
Vascular disorders
Deep vein thrombosis ^† 1	1/207 (0.48%)	0/209 (0.00%)
Hypotension ^† 1	2/207 (0.97%)	2/209 (0.96%)
1 Term from vocabulary, MedDRA (22.0) † Indicates events were collected by systematic assessment
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	199/207 (96.14%)	196/209 (93.78%)
Blood and lymphatic system disorders
Anaemia ^† 1	54/207 (26.09%)	48/209 (22.97%)
Leukopenia ^† 1	17/207 (8.21%)	10/209 (4.78%)
Neutropenia ^† 1	129/207 (62.32%)	113/209 (54.07%)
Thrombocytopenia ^† 1	41/207 (19.81%)	46/209 (22.01%)
Gastrointestinal disorders
Abdominal pain ^† 1	21/207 (10.14%)	13/209 (6.22%)
Constipation ^† 1	32/207 (15.46%)	35/209 (16.75%)
Diarrhoea ^† 1	89/207 (43.00%)	47/209 (22.49%)
Dyspepsia ^† 1	15/207 (7.25%)	8/209 (3.83%)
Nausea ^† 1	60/207 (28.99%)	72/209 (34.45%)
Vomiting ^† 1	35/207 (16.91%)	31/209 (14.83%)
General disorders
Asthenia ^† 1	24/207 (11.59%)	20/209 (9.57%)
Chills ^† 1	22/207 (10.63%)	13/209 (6.22%)
Fatigue ^† 1	45/207 (21.74%)	52/209 (24.88%)
Oedema peripheral ^† 1	17/207 (8.21%)	18/209 (8.61%)
Pyrexia ^† 1	78/207 (37.68%)	55/209 (26.32%)
Immune system disorders
Hypogammaglobulinaemia ^† 1	12/207 (5.80%)	10/209 (4.78%)
Infections and infestations
Bronchitis ^† 1	20/207 (9.66%)	8/209 (3.83%)
Herpes zoster ^† 1	11/207 (5.31%)	6/209 (2.87%)
Lower respiratory tract infection ^† 1	13/207 (6.28%)	10/209 (4.78%)
Nasopharyngitis ^† 1	16/207 (7.73%)	11/209 (5.26%)
Pneumonia ^† 1	25/207 (12.08%)	13/209 (6.22%)
Respiratory tract infection ^† 1	7/207 (3.38%)	11/209 (5.26%)
Sinusitis ^† 1	19/207 (9.18%)	13/209 (6.22%)
Upper respiratory tract infection ^† 1	37/207 (17.87%)	21/209 (10.05%)
Injury, poisoning and procedural complications
Infusion related reaction ^† 1	29/207 (14.01%)	45/209 (21.53%)
Investigations
Alanine aminotransferase increased ^† 1	32/207 (15.46%)	2/209 (0.96%)
Aspartate aminotransferase increased ^† 1	19/207 (9.18%)	2/209 (0.96%)
Weight decreased ^† 1	25/207 (12.08%)	12/209 (5.74%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	24/207 (11.59%)	15/209 (7.18%)
Hypokalaemia ^† 1	21/207 (10.14%)	16/209 (7.66%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	27/207 (13.04%)	16/209 (7.66%)
Back pain ^† 1	17/207 (8.21%)	15/209 (7.18%)
Nervous system disorders
Headache ^† 1	20/207 (9.66%)	21/209 (10.05%)
Psychiatric disorders
Anxiety ^† 1	6/207 (2.90%)	12/209 (5.74%)
Insomnia ^† 1	19/207 (9.18%)	13/209 (6.22%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	52/207 (25.12%)	47/209 (22.49%)
Dyspnoea ^† 1	20/207 (9.66%)	26/209 (12.44%)
Oropharyngeal pain ^† 1	10/207 (4.83%)	14/209 (6.70%)
Productive cough ^† 1	17/207 (8.21%)	12/209 (5.74%)
Skin and subcutaneous tissue disorders
Night sweats ^† 1	18/207 (8.70%)	8/209 (3.83%)
Pruritus ^† 1	17/207 (8.21%)	12/209 (5.74%)
Rash ^† 1	36/207 (17.39%)	28/209 (13.40%)
Vascular disorders
Hypertension ^† 1	13/207 (6.28%)	5/209 (2.39%)
Hypotension ^† 1	14/207 (6.76%)	13/209 (6.22%)
1 Term from vocabulary, MedDRA (22.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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:	ClinicalTrialDisclosures@gilead.com

Publications:

Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.

Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.

Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.

Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA

Zelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illes A, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Montillo M, Illes A, Robak T, Pristupa AS, Wach M, Egyed M, Delgado J, Jurczak W, Morschhauser F, Schuh A, Eradat H, Shreay S, Barrientos JC, Zelenetz AD. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019 Nov 15;17(1):173. doi: 10.1186/s12955-019-1232-8.

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01569295
Other Study ID Numbers:	GS-US-312-0115 2011-006292-20 ( EudraCT Number )
First Submitted:	March 27, 2012
First Posted:	April 3, 2012
Results First Submitted:	December 18, 2017
Results First Posted:	February 27, 2018
Last Update Posted:	March 10, 2020

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