A Study of Duvelisib in Combination With Rituximab or Obi... | NCT02391545

ID	Type	Description	Link
2014-005459-13	EudraCT Number

Label	Type	Description	Intervention Names
Duvelisib and Rituximab	Experimental	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.	Drug: Duvelisib Drug: Rituximab
Duvelisib and Obinutuzumab	Experimental	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.	Drug: Duvelisib Drug: Obinutuzumab

Name	Type	Description	Arm Group Labels	Other Names
Duvelisib	Drug	PI3K Inhibitor	Duvelisib and Obinutuzumab Duvelisib and Rituximab

Measure	Description	Time Frame
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1		28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2		Up to 2 years from the first dose of study treatment

Measure	Description	Time Frame
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values	Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.	Up to 30 days after the last dose of study treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of CD20+, follicular lymphoma that has not been treated
CD20-immunophenotyping of tumor to document B-cell follicular lymphoma
Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease
Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)
At least one measurable lesion that is > 1.5 cm in at least one dimension
Eastern Cooperative Oncology Group (ECOG) performance status <=2 (corresponds to Karnofsky Performance Status [KPS] >=60%)

Exclusion Criteria:

Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.
Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma
Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
Prior allogeneic hematopoietic stem cell transplant
Prior, current or chronic hepatitis B or hepatitis C infection
Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection

Name	Affiliation	Role
Hagop Youssoufian, MD	Verastem, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90095	United States

ID	Title	Description
FG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Obinutuzumab

ID	Title	Description
BG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Obinutuzumab
BG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Rituximab
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00027 BG00128 BG00255

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1

Posted

Count of Participants

Participants

28 days from first dose of study treatment

ID	Title	Description
OG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab
OG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab

Units	Counts
Participants	OG00027 OG00128

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010

Primary

Complete Response Rate (CRR)- Part 2

Posted

Count of Participants

Participants

Up to 2 years from the first dose of study treatment

ID	Title	Description
OG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab
OG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab

Units	Counts
Participants

Secondary

Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values

Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.

Posted

Count of Participants

Participants

Up to 30 days after the last dose of study treatment

ID	Title	Description
OG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab
OG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab

Secondary

Overall Response Rate (ORR)

Posted

Number

participants

Up to 2 years from the first dose of study treatment

ID	Title	Description
OG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab
OG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab

Units	Counts
Participants	OG000

Secondary

Duration of Response (DOR)

The median DOR was non-estimable.

Data could not be reported because the study was terminated early and a sufficient number of subjects and events were not available for analysis.

Posted

Up to 2 years from the first dose of study treatment

ID	Title	Description
OG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab
OG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab

Units	Counts

Secondary

Overall Survival (OS)

The study had been terminated and Overall Survival was not performed.

Posted

Up to 2 years from the first dose of study treatment

ID	Title	Description
OG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab
OG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab

Units	Counts
Participants

Secondary

Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)

Plasma concentrations of Duvelisib and IPI-656 (metabolite)

The study had been terminated and PK analysis was not performed.

Posted

Every 4 weeks for 16 weeks

ID	Title	Description
OG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab
OG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab

Units	Counts

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0014 affected28 at risk
Odynophagia	Gastrointestinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Pyrexia	General disorders	Systematic Assessment	EG0004 affected27 at risk EG0012 affected28 at risk
Fatigue	General disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Mucosal Inflammation	General disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Hepatotoxicity	Hepatobiliary disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Hepatitis	Hepatobiliary disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Conjuctivitis	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Diarrhoea infectious	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Klebsiella infection	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Pneumonia respiratory synctial viral	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Pylonephritis	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Septic Shock	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Cytomegalovirus infection	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Pneumocystis jirovecii infection	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Pneumonia Cytomegaloviral	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Pneumonia pneumococcal	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0011 affected28 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Rash papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk
Rash generalised	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk
Embolism	Vascular disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0005 affected27 at risk EG0014 affected28 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00012 affected27 at risk EG0017 affected28 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00011 affected27 at risk EG00116 affected28 at risk
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG0008 affected27 at risk EG0015 affected28 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0008 affected27 at risk EG0013 affected28 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0005 affected27 at risk EG0012 affected28 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0004 affected27 at risk EG0015 affected28 at risk
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0004 affected27 at risk EG0011 affected28 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0003 affected27 at risk EG0013 affected28 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk
Fatigue	General disorders	Systematic Assessment	EG0008 affected27 at risk EG0019 affected28 at risk
Pyrexia	General disorders	Systematic Assessment	EG0008 affected27 at risk EG0016 affected28 at risk
Asthenia	General disorders	Systematic Assessment	EG0004 affected27 at risk EG0015 affected28 at risk
Malaise	General disorders	Systematic Assessment	EG0004 affected27 at risk EG0011 affected28 at risk
Mucosal Inflammation	General disorders	Systematic Assessment	EG0002 affected27 at risk EG0013 affected28 at risk
Chills	General disorders	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk
Drug Hypersensitivity	Immune system disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0006 affected27 at risk EG0011 affected28 at risk
Conjuctivitis	Infections and infestations	Systematic Assessment	EG0004 affected27 at risk EG0011 affected28 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0002 affected27 at risk EG0012 affected28 at risk
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 affected27 at risk EG0011 affected28 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG00013 affected27 at risk EG0019 affected28 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG00013 affected27 at risk EG0018 affected28 at risk
Amylase increased	Investigations	Systematic Assessment	EG0003 affected27 at risk EG0013 affected28 at risk
Lipase increased	Investigations	Systematic Assessment	EG0003 affected27 at risk EG0013 affected28 at risk
Transaminases increased	Investigations	Systematic Assessment	EG0001 affected27 at risk EG0013 affected28 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0006 affected27 at risk EG0010 affected28 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected27 at risk EG0011 affected28 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 affected27 at risk EG0016 affected28 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0013 affected28 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0004 affected27 at risk EG0011 affected28 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0004 affected27 at risk EG0014 affected28 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0003 affected27 at risk EG0015 affected28 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 affected27 at risk EG0017 affected28 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected27 at risk EG0012 affected28 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0014 affected28 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0007 affected27 at risk EG0017 affected28 at risk
Dry Skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 affected27 at risk EG0012 affected28 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk
Pruritis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected27 at risk EG0013 affected28 at risk
Rash generalised	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk
Orthostatic Hypotension	Vascular disorders	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0000 affected27 at risk EG0013 affected28 at risk

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Duvelisib and Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Obinutuzumab	0	27	16	27	26	27
EG001	Duvelisib and Rituximab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Rituximab	1	28	10	28	27	28