Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

B-cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Fludarabine

Fludarabine phosphate

Everolimus

Bendamustine Hydrochloride

Rituximab

Immunomodulating Agents

Lenalidomide

Bortezomib

Immunoglobulins

Ofatumumab

Chlorambucil

Idelalisib

Antineoplastic Agents, Immunological

Immunologic Factors

Immunosuppressive Agents

Angiogenesis Inhibitors

Growth Inhibitors

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Participants with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL) will receive treatments as follows:

Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID) on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 intravenously (IV) on Days 1, 8, 15 \& 22, Cycles 1 \& 2

Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Participants with CLL, iNHL and mantle cell lymphoma (MCL) will receive treatments as follows:

Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle from Cycles 1 - 6

Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Participants with CLL and iNHL will receive treatments as follows:

Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Participants with CLL will receive treatments as follows:

Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))

Participants with CLL will receive treatments as follows:

Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m\^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6

Participants with MCL will receive treatments as follows:

Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle

Participants with MCL will receive treatments as follows:

Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m\^2 subcutaneously on Days 1, 8 \& 15 of each 28-day cycle

Participants with CLL will receive treatments as follows:

Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Participants with CLL will receive treatments as follows:

Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Participants with CLL and iNHL will receive treatments as follows:

Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) \& Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of Cycle 1 \& Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) \& Days 1 - 21 of next five 28-day cycles

Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) \& Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of Cycle 1 \& Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) \& Days 1 - 21 of next five 28-day cycles

Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) \& Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of Cycle 1 \& Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) \& Days 1 - 21 of next five 28-day cycles

Bendamustine

Everolimus administered orally twice daily until disease progression

Bortezomib administered as a subcutaneous injection

Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.

Gilead Study Director

The primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Duration of exposure to IDELA was summarized using descriptive statistics.

Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02

Overall Response Rate (ORR) was defined as the percentage of participants achieving a complete response (CR) or partial response (PR).

The response definitions were based on the following standard criteria established for each indication:

* CLL: International Workshop on chronic lymphocytic leukemia (IWCLL),2008
* iNHL \& MCL: Cheson, 2007

Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.

Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR.

Progression free survival (PFS) was defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause.

The response definitions were based on the following standard criteria established for each indication:

* CLL: International Workshop on chronic lymphocytic leukemia (IWCLL), 2008
* iNHL \& MCL: Cheson, 2007

Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause.

Gilead Sciences

The ITT analysis set included participants who received at least 1 dose of study drug (IDELA or combination drugs). Per prespecified analysis, participants were grouped by disease (CLL, iNHL, MCL) and by treatment regimen (cohort).

Participants with chronic CLL and iNHL received treatments as follows:

Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15 \& 22, Cycles 1 \& 2

Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Idelalisib + Rituximab

Participants with CLL and iNHL received treatments as follows:

Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Idelalisib + Bendamustine

Participants with MCL received treatments as follows:

Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle

Idelalisib + Everolimus

Participants with MCL received treatments as follows:

Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m\^2 subcutaneously on Days 1, 8 \& 15 of each 28-day cycle

Idelalisib + Bortezomib

Participants with CLL, iNHL and MCL received treatments as follows:

Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle from Cycles 1 - 6

Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Idelalisib + Rituximab + Bendamustine

Participants with CLL received treatments as follows:

Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))

Idelalisib + Ofatumumab

Participants with CLL received treatments as follows:

Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m\^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6

Idelalisib + Fludarabine

Participants with CLL received treatments as follows:

Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Idelalisib + Chlorambucil

Participants with CLL received treatments as follows:

Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Idelalisib + Rituximab + Chlorambucil

Participants with CLL and iNHL received treatments as follows:

Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles

Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles

Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles

Idelalisib + Rituximab + Lenalidomide

Participants with CLL and iNHL received treatments as follows:

Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15 \& 22, Cycles 1 \& 2

Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

The intent-to-treat (ITT) analysis set included participants who received at least 1 dose of study drug (Idelalisib or combination drugs). Per prespecified analysis, participants were grouped by disease (CLL, iNHL, MCL) and by treatment regimen (cohort).

Gilead Clinical Study Information Center

The ITT analysis set included participants who received at least 1 dose of study drug (idelalisib or combination drugs). Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Duration of Exposure to IDELA

Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Toxicity of Administration of IDELA

Overall Response Rate

Participants in the ITT analysis set with available data were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Duration of Response

Time to Response

Progression-free Survival

Overall Survival

Pre-dose (Week 0)

0.5 hr post-dose (Week 0)

1.0 hr post-dose (Week 0)

1.5 hr post-dose (Week 0)

2.0 hr post-dose (Week 0)

3.0 hr post-dose (Week 0)

4.0 hr post-dose (Week 0)

6.0 hr post-dose (Week 0)

Pre-dose (Week 4)

1.5 hr post-dose (Week 4)

Pre-dose (Week 12)

1.5 hr post-dose (Week 12)

Pre-dose (Week 24)

1.5 hr post-dose (Week 24)

Participants analyzed for this group included participants from Cohort 1 (subcohort 1a and 1b) who received the treatments as follows:

Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15 \& 22, Cycles 1 \& 2

Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycle 1 - 6

Idelalisib 100 mg (Cohort 1)

Participants analyzed for this group included participants from Cohort 2a, 2b, 3a, 3b, 3c, 3e, 3f, 3g who received the treatments as follows:

Cohort 2a: IDELA 150 mg orally (po) BID, D1 - D28 of each cycle + rituximab 375 mg/m\^2 IV on D1, D8, D15, \& D22, C1 \& C2

Cohort 2b: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m\^2 IV, D1 \& D2, C1 - C6

Cohorts 3a and 3b: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m\^2 IV on D1, C1 - C6 + bendamustine 90 mg/m\^2 (Cohort 3a only) IV, D1 \& D2, C1 - C6 + bendamustine 70 mg/m\^2 (Cohort 3b only) IV on D1 \& D2, C1 - C6

Cohort 3c: IDELA 150 mg po BID, D1 - D28 of each cycle + ofatumumab 12 doses (300 mg (D1 or D2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))

Cohort 3d: IDELA 150 mg po BID, D1 - D28 of each cycle + fludarabine 40 mg/m\^2 po D1 - D5, C1 - C6

Cohort 3e: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m\^2 IV on D1, D8, D15, \& D22, C1 \& C2

Cohorts 3f and 3g: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m\^2 (cohort 3f only) IV, D1 \& D2, C1 - C6 + bendamustine 70 mg/m\^2 (Cohort 3g only) IV, D1 \& D2, C1 - C6

C= Cycle D= Day Cycle length= 28 days

Idelalisib 150 mg (Cohorts 2 and 3)

Participants analyzed for this group included participants from Cohort 5 (subcohorts 5a, 5b, and 5c) who received the treatments as follows:

Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle

Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m\^2 subcutaneously on Days 1, 8 \& 15 of each 28-day cycle

Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Idelalisib 150 mg (Cohort 5)

The pharmacokinetic (PK) analysis set included data from participants in the ITT analysis set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest. Per prespecified analysis, data were summarized for participants in Cohort 1a 1b, who received idelalisib 100 mg and for participants in Cohorts 2a, 2b, 3a, 3b, 3c, 3d, 3e, 3f, 3g 5a, 5b, and 5c who received idelalisib 150 mg.

Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5)

0.5 hr post-dose (Week 4)

1.0 hr post-dose (Week 4)

2.0 hr post-dose (Week 4)

3.0 hr post-dose (Week 4)

4.0 hr post-dose (Week 4)

6.0 hr post-dose (Week 4)

Participants analyzed for this group included participants from Cohort 4 (subcohorts 4a and 4b) who received the treatments as follows:

Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Idelalisib 150 mg (Cohort 4)

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 4a, 4b who received idelalisib 150mg.

Plasma Concentration of IDELA (Cohort 4)

Participants analyzed for this group included participants from Cohort 6 (subcohorts 6a and 6b) who received the treatments as follows

Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Idelalisib 150 mg (Cohort 6)

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 6a, 6b who received idelalisib 150mg.

Plasma Concentration of IDELA (Cohort 6)

Pre-dose (Week 5)

1.5 hr post-dose (Week 5)

Pre-dose (Week 13)

1.5 hr post-dose (Week 13)

Participants analyzed for this group included participants from Cohort 7 (subcohorts 7a, 7b, and 7c) who received the treatments as follows:

Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles

Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles

Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles

Idelalisib 150 mg (Cohort 7)

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 7a, 7b, 7c who received idelalisib 150mg.

Plasma Concentration of IDELA (Cohort 7)

Pre-dose

0.5 hr post-dose

1.0 hr post-dose

1.5 hr post-dose

2.0 hr post-dose

3.0 hr post-dose

4.0 hr post-dose

6.0 hr post-dose

Participants analyzed for this group included participants from Cohort 1 who received the treatments as follows:

Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15 \& 22, Cycles 1 \& 2

Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Idelalisib 100 mg (Cohort 1a, 1b)

Participants included for analysis received treatments as follows:

Cohort 2a: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m\^2 IV on D1, D8, D15, \& D22, C1 \& C2

Cohort 2b: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m\^2 IV, D1 \& D2, C1 - C6

Cohorts 3a and 3b: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m\^2 IV on D1, C1 - C6 + bendamustine 90 mg/m\^2 (Cohort 3a only) IV, D1 \& D2, C1 - C6 + bendamustine 70 mg/m\^2 (Cohort 3b only) IV on D1 \& D2, C1 - C6

Cohort 3c: IDELA 150 mg po BID, D1 - D28 of each cycle + ofatumumab 12 doses (300 mg (D1 or D2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))

Cohort 3d: IDELA 150 mg po BID, D1 - D28 of each cycle + fludarabine 40 mg/m\^2 po D1 - D5, C1 - C6

Cohort 3e: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m\^2 IV on D1, D8, D15, \& D22, C1 \& C2

Cohorts 3f and 3g: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m\^2 (Cohort 3f only) IV, D1 \& D2, C1 - C6 + bendamustine 70 mg/m\^2 (Cohort 3g only) IV, D1 \& D2, C1 - C6

Cohort 4a: IDELA 150 mg po BID, D1 - D28 of each cycle (starting C2 D1) + rituximab 375 mg/m\^2 IV, D1, D8, D15, \& D22, C1 \& C2

Cohort 4b: IDELA 150 mg po BID, D1 - D28 of each cycle (starting C2, D3) + bendamustine 90 mg/m\^2 IV, D1 \& D2, C1 - C6

C= Cycle D= Day Cycle length= 28 days

Idelalisib 150 mg (Cohorts 2a, 2b, 3a, 3c, 3d, 3e, 3f, 3g, 4a, 4b)

Participants with CLL or iNHL from the PK Analysis Set in Cohorts 1, 2, 3, and 4 who participated in the PK substudy were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 1a, 1b who received idelalisib 100mg and Cohorts 2a, 2b, 3a, 3c, 3d, 3e, 3f, 3g, 4a, 4b who received idelalisib 150 mg in the PK substudy.

Sub-study: Plasma Concentration of IDELA (Cohorts 1-4)

0.25 hr post-dose (Week 0)

0.75 hr post-dose (Week 0)

1.25 hr post-dose (Week 0)

5.0 hr post-dose (Week 0)

Participants included for analysis received treatments as follows:

Cohort 1b: IDELA 100 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 2b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3a: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle from Cycles 1 - 6

Cohort 3f: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3g: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 4b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6

Cohort 5c: IDELA 150 mg po BID on Days 1 - 28 + rituximab 375 mg/m\^2 IV on Day 1, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2, Cycles 1 - 6 (Cycle length= 28 days)

Bendamustine (Cohorts 1b, 2b, 3a, 3b, 3f, 3g, 4b, 5c)

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohorts 1b, 2b, 3a, 3b, 3f, 3g, 4b, 5c who received bendamustine.

Plasma Concentration of Bendamustine

Participants analyzed for this group included participants from Cohort 5 (subcohort 5a) who received the treatments as follows:

Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle

Everolimus (Cohort 5a)

Participants in the PK analysis set with available data were analyzed. Data were summarized for participants in Cohort 5a who received everolimus.

Plasma Concentration of Everolimus

Pre-dose (Week 1)

1.5 hr post-dose (Week 1)

Lenalidomide (Cohort 7a, 7b, 7c)

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 7a, 7b, 7c who received lenalidomide.

Plasma Concentration of Lenalidomide

Participants with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL) received treatments as follows:

Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID) on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 intravenously (IV) on Days 1, 8, 15 \& 22, Cycles 1 \& 2

Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2

Participants with mantle cell lymphoma (MCL) received treatments as follows:

Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle

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