Trial Outcomes & Findings for An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study (NCT NCT01090414)

Last Updated: 2019-08-28

Results Overview

Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

202 participants

Primary outcome timeframe

Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Results posted on

2019-08-28

Participant Flow

Participants were enrolled at study sites in the United States. The first participant was screened on 22 March 2010. The last study visit occurred on 18 June 2018.

Participants must have been enrolled in a previous Gilead-sponsored study.

Participant milestones

Participant milestones
Measure	101-02 Participants with chronic lymphocytic leukemia (CLL), indolent non-Hodgkin lymphoma (iNHL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), or multiple myeloma (MM) received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. Note: Only participants from Cohort 1 were eligible to enter this Study 101-99, so Cohort 2 participants are not presented at all in this record.	101-10 Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Parent Studies STARTED	191	241	64	18
Parent Studies COMPLETED	50	114	43	5
Parent Studies NOT COMPLETED	141	127	21	13
Study 101-99 STARTED	48	108	41	5
Study 101-99 COMPLETED	0	0	0	0
Study 101-99 NOT COMPLETED	48	108	41	5

Reasons for withdrawal

Reasons for withdrawal
Measure	101-02 Participants with chronic lymphocytic leukemia (CLL), indolent non-Hodgkin lymphoma (iNHL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), or multiple myeloma (MM) received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. Note: Only participants from Cohort 1 were eligible to enter this Study 101-99, so Cohort 2 participants are not presented at all in this record.	101-10 Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Study 101-99 Progressive Disease	28	48	10	4
Study 101-99 Adverse Event	10	28	18	0
Study 101-99 Investigator Request	1	11	4	0
Study 101-99 Death	3	8	1	0
Study 101-99 Sponsor Discontinued Study	0	7	5	0
Study 101-99 Other (Unknown Reasons)	3	3	0	0
Study 101-99 Withdrew Consent	0	2	3	1
Study 101-99 Participant Request	3	1	0	0

Baseline Characteristics

An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	101-02 n=191 Participants Participants with CLL, iNHL, MCL, DLBCL, AML, or MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 n=241 Participants Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 n=64 Participants Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-10 n=18 Participants Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.	Total n=514 Participants Total of all reporting groups
Age, Customized < 65 years	86 Participants n=5 Participants	116 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants	215 Participants n=21 Participants
Age, Customized ≥ 65 years	105 Participants n=5 Participants	125 Participants n=7 Participants	64 Participants n=5 Participants	5 Participants n=4 Participants	299 Participants n=21 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	76 Participants n=7 Participants	24 Participants n=5 Participants	8 Participants n=4 Participants	160 Participants n=21 Participants
Sex: Female, Male Male	139 Participants n=5 Participants	165 Participants n=7 Participants	40 Participants n=5 Participants	10 Participants n=4 Participants	354 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	167 Participants n=5 Participants	234 Participants n=7 Participants	64 Participants n=5 Participants	17 Participants n=4 Participants	482 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	25 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	160 Participants n=5 Participants	209 Participants n=7 Participants	61 Participants n=5 Participants	12 Participants n=4 Participants	442 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Race · Not Reported	22 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	33 Participants n=21 Participants
Diagnosis Status Chronic lymphocytic leukemia (CLL)	54 Participants n=5 Participants	115 Participants n=7 Participants	59 Participants n=5 Participants	0 Participants n=4 Participants	228 Participants n=21 Participants
Diagnosis Status Indolent non-Hodgkin lymphoma (iNHL)	64 Participants n=5 Participants	86 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants	172 Participants n=21 Participants
Diagnosis Status Mantle cell lymphoma (MCL)	40 Participants n=5 Participants	40 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	80 Participants n=21 Participants
Diagnosis Status Diffuse large B-cell lymphoma (DLBCL)	9 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Diagnosis Status Acute myeloid leukemia (AML)	12 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	12 Participants n=21 Participants
Diagnosis Status Multiple myeloma (MM)	12 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	12 Participants n=21 Participants
Diagnosis Status Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Population: Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Outcome measures

Outcome measures
Measure	101-02 (AML) n=12 Participants Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (CLL) n=54 Participants Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (DLBCL) n=9 Participants Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (iNHL) n=64 Participants Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MCL) n=40 Participants Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MM) n=12 Participants Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (CLL) n=115 Participants Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (iNHL) n=86 Participants Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (MCL) n=40 Participants Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 (CLL or SLL) n=64 Participants Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-10 (iNHL) n=18 Participants Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Overall Response Rate	0 percentage of participants Interval 0.0 to 0.0	57.4 percentage of participants Interval 43.2 to 70.8	11.1 percentage of participants Interval 0.3 to 48.2	48.4 percentage of participants Interval 35.8 to 61.3	40.0 percentage of participants Interval 24.9 to 56.7	0 percentage of participants Interval 0.0 to 0.0	81.7 percentage of participants Interval 73.5 to 88.3	82.6 percentage of participants Interval 72.9 to 89.9	57.5 percentage of participants Interval 40.9 to 73.0	96.9 percentage of participants Interval 89.2 to 99.6	44.4 percentage of participants Interval 21.5 to 69.2

PRIMARY outcome

Timeframe: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days

Population: Data presented includes data from both the parent studies and this Study 101-99. For this safety endpoint, data was prespecified to be combined.

Outcome measures

Outcome measures
Measure	101-02 (AML) n=191 Participants Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (CLL) n=241 Participants Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (DLBCL) n=64 Participants Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (iNHL) n=18 Participants Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MCL) Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MM) Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (CLL) Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (iNHL) Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (MCL) Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 (CLL or SLL) Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-10 (iNHL) Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events	98.4 percentage of participants	98.8 percentage of participants	100.0 percentage of participants	94.4 percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Population: Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.

Outcome measures

Outcome measures
Measure	101-02 (AML) n=12 Participants Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (CLL) n=54 Participants Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (DLBCL) n=9 Participants Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (iNHL) n=64 Participants Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MCL) n=40 Participants Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MM) n=12 Participants Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (CLL) n=115 Participants Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (iNHL) n=86 Participants Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (MCL) n=40 Participants Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 (CLL or SLL) n=64 Participants Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-10 (iNHL) n=18 Participants Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Duration of Response	NA Months NA = No participants achieved complete or partial response.	21.2 Months Interval 8.1 to 30.4	NA Months NA = not reached; Too few events to estimate the median and the lower and upper limits of the confidence interval.	18.4 Months Interval 10.9 to 32.4	2.7 Months Interval 1.0 to 8.1	NA Months NA = No participants achieved complete or partial response.	26.6 Months Interval 18.5 to 44.1	42.9 Months Interval 20.5 to 83.3	9.3 Months Interval 5.6 to 37.5	63.8 Months Interval 54.0 to NA = Not reached; Too few events to estimate the upper limit of the confidence interval.	14.4 Months Interval 6.6 to 46.3

SECONDARY outcome

Timeframe: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Population: Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates.

Outcome measures

Outcome measures
Measure	101-02 (AML) n=12 Participants Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (CLL) n=54 Participants Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (DLBCL) n=9 Participants Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (iNHL) n=64 Participants Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MCL) n=40 Participants Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MM) n=12 Participants Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (CLL) n=115 Participants Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (iNHL) n=86 Participants Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (MCL) n=40 Participants Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 (CLL or SLL) n=64 Participants Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-10 (iNHL) n=18 Participants Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Progression-Free Survival	0.9 Months Interval 0.4 to 1.0	15.8 Months Interval 5.6 to 39.6	1.5 Months Interval 0.3 to 4.1	7.6 Months Interval 3.7 to 17.7	3.7 Months Interval 2.7 to 8.2	1 Months Interval 0.9 to 1.8	26.1 Months Interval 19.0 to 36.8	32.8 Months Interval 22.0 to 81.3	11.1 Months Interval 3.4 to 12.9	65.6 Months Interval 55.8 to NA = Not reached; Too few events to estimate the upper limit of the confidence interval.	10.2 Months Interval 2.8 to 19.1

SECONDARY outcome

Timeframe: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Population: Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Overall survival (OS) was defined as the interval from the start of study treatment in the parent study to death from any cause. OS was analyzed using KM estimates.

Outcome measures

Outcome measures
Measure	101-02 (AML) n=12 Participants Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (CLL) n=54 Participants Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (DLBCL) n=9 Participants Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (iNHL) n=64 Participants Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MCL) n=40 Participants Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MM) n=12 Participants Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (CLL) n=115 Participants Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (iNHL) n=86 Participants Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (MCL) n=40 Participants Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 (CLL or SLL) n=64 Participants Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-10 (iNHL) n=18 Participants Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Overall Survival	NA Months NA = not reached; Too few events to estimate the median and the lower and upper limits of the confidence interval.	NA Months Interval 39.7 to NA = not reached; Too few events to estimate the median and upper limit of the confidence interval.	NA Months NA = not reached; Too few events to estimate the median and the lower and upper limits of the confidence interval.	NA Months NA = not reached; Too few events to estimate the median and the lower and upper limits of the confidence interval.	NA Months NA = not reached; Too few events to estimate the median and the lower and upper limits of the confidence interval.	5.2 Months Interval 1.2 to 5.2	NA Months Interval 50.2 to NA = not reached; Too few events to estimate the median and upper limit of the confidence interval.	NA Months NA = not reached; Too few events to estimate the median and the lower and upper limits of the confidence interval.	NA Months NA = not reached; Too few events to estimate the median and the lower and upper limits of the confidence interval.	NA Months Interval 66.3 to NA = not reached; Too few events to estimate the median and upper limit of the confidence interval.	NA Months Interval 10.3 to NA = not reached; Too few events to estimate the median and upper limit of the confidence interval.

SECONDARY outcome

Timeframe: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Population: Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response.

Outcome measures

Outcome measures
Measure	101-02 (AML) Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (CLL) n=31 Participants Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (DLBCL) n=1 Participants Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (iNHL) n=31 Participants Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MCL) n=16 Participants Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-02 (MM) Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (CLL) n=94 Participants Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (iNHL) n=71 Participants Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-07 (MCL) n=23 Participants Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-08 (CLL or SLL) n=62 Participants Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	101-10 (iNHL) n=8 Participants Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
Time to Response	—	1.9 Months Interval 1.0 to 7.5	4.0 Months Interval 4.0 to 4.0	1.3 Months Interval 1.0 to 3.7	1.1 Months Interval 1.0 to 1.9	—	1.9 Months Interval 1.9 to 1.9	1.9 Months Interval 1.9 to 3.0	1.9 Months Interval 1.9 to 2.0	1.9 Months Interval 1.9 to 1.9	2.7 Months Interval 2.6 to 3.1

Adverse Events

101-02

Serious events: 100 serious events

Other events: 183 other events

Deaths: 25 deaths

101-07

Serious events: 165 serious events

Other events: 236 other events

Deaths: 36 deaths

101-08

Serious events: 45 serious events

Other events: 63 other events

Deaths: 7 deaths

101-10

Serious events: 6 serious events

Other events: 16 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER