CITADEL-203: A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03126019
• Collaborator: (none)
• Enrollment: 126
• Locations: 83
• Arms: 2
• Anticipated Duration (Months): 60.6
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Parsaclisib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
• Actual Study Start Date: Mar 14, 2018
• Actual Primary Completion Date: Feb 26, 2021
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Drug: Parsaclisib; Parsaclisib tablets administered orally with water and without regard to food; Other Names: INCB050465
Experimental: Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.	Drug: Parsaclisib; Parsaclisib tablets administered orally with water and without regard to food; Other Names: INCB050465

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria [Up to approximately 148 weeks]

   ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions.

Secondary Outcome Measures

1. Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria [Up to approximately 148 weeks]

   CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas as determined by an IRC. The criteria for CR included: 1. Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3. Organ enlargement regressed to normal; 4. No new lesions; 5. Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.

2. Duration of Response (DOR) [Up to approximately 148 weeks]

   DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.

3. Progression-free Survival (PFS) With Parsaclisib [Up to approximately 148 weeks]

   PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.

4. Overall Survival (OS) With Parsaclisib [Up to approximately 148 weeks]

   OS was defined as the time from the date of the first dose of study treatment until death from any cause.

5. Best Percent Change From Baseline in Target Lesion Size [Up to approximately 148 weeks]

   Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.

6. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [From first dose of study drug up to approximately 148 weeks]

   An adverse event (AE) is defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged 18 years or older.

• Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.

• Ineligible for hematopoietic stem cell transplant.

• Must have been treated with at least 2 prior systemic therapies.

• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.

• Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

• Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

• History of central nervous system lymphoma (either primary or metastatic).

• Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan-PI3K inhibitor.

• Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

• Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.

• Active graft-versus-host disease.

• Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Associates - Biltmore Cancer Center	Phoenix	Arizona	United States	85016
2	Beverly Hills Cancer Center	Beverly Hills	California	United States	90211
3	Synergy Hematology and Oncology Medical Associates	Los Angeles	California	United States	90036
4	St. Joseph Heritage Healthcare	Santa Rosa	California	United States	95403
5	American Institute of Research Corporate Office	Whittier	California	United States	90603
6	Cancer Center of Central Connecticut	Southington	Connecticut	United States	06489
7	Florida Cancer Specialists & Research Institute	Fort Myers	Florida	United States	33901
8	Asclepes Research Centers	Spring Hill	Florida	United States	34606
9	Clinical Trials of Swla Llc	Lake Charles	Louisiana	United States	70601
10	Saint Agnes Hospital	Baltimore	Maryland	United States	21229
11	Barbara Ann Karmanos Cancer Hospital	Detroit	Michigan	United States	48201
12	Hattiesburg Clinic Hematology	Hattiesburg	Mississippi	United States	39401
13	Saint Luke'S Hospital	Kansas City	Missouri	United States	64111
14	Sarah Cannon Research Institute	Kansas City	Missouri	United States	64132
15	Clinical Research Alliance, Inc.	New Hyde Park	New York	United States	11042
16	Duke University Medical Center	Durham	North Carolina	United States	27710
17	Gabrail Cancer Center	Canton	Ohio	United States	44718
18	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104
19	Charleston Hematology Oncology Associates Pa	Charleston	South Carolina	United States	29414
20	Tennessee Oncology	Nashville	Tennessee	United States	37203
21	Renovatio Clinical Consultants Llc	Spring	Texas	United States	77380
22	University of Washington	Seattle	Washington	United States	98109
23	Western Health	St Albans	Victoria	Australia	03021
24	Border Medical Oncology	Wodonga	Victoria	Australia	03690
25	St Vincent'S Hospital Sydney	Darlinghurst		Australia	02010
26	Saint John Regional Hospital	St. John	New Brunswick	Canada	E2L 4L2
27	Sunnybrook Health Science Centre	Toronto	Ontario	Canada	M4N 3M5
28	Santa Cabrini Hospital	Montreal	Quebec	Canada	H1T 1P7
29	University Hospital Hradec Kralove	Hradec Kralove		Czechia	500 05
30	Fakultni Nemocnice Ostrava	Ostrava		Czechia	708 52
31	University Hospital Kralovkse Vinohrady	Prague		Czechia	10034
32	Fakultni Nemocnice V Motole	Praha 5		Czechia	15000
33	Univerzita Karlova V Praze 1. Lekarska Fakulta	Praha		Czechia	120 0
34	Aalborg University Hospital	Aalborg		Denmark	09000
35	Odense Universitetshospital (Ouh) (Odense University Hospital)	Odense C		Denmark	05000
36	Bag Arnoldstr. Dresden	Dresden		Germany	01307
37	University Medical Center Freiburg	Freiburg		Germany	79106
38	Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii	Mainz		Germany	55131
39	University Hospital Mannheim	Mannheim		Germany	68167
40	Semmelweis Egyetem	Budapest		Hungary	01085
41	National Institute of Oncology	Budapest		Hungary	01122
42	University of Debrecen	Debrecen		Hungary	04032
43	Somogy Medyei Kaposi Mor Oktato Korhaz	Kaposvar		Hungary	07400
44	Hillel Yafe Medical Center (Hymc)	Hadera		Israel	38100
45	Rambam Medical Center	Haifa		Israel	31096
46	Laniado Hospital Hematology	Netanya		Israel	42150
47	Sheba Medical Center	Ramat Gan		Israel	52621
48	Tel Aviv Sourasky Medical Center	Tel Aviv-yafo		Israel	64239
49	Irccs Centro Di Riferimento Oncologico	Aviano		Italy	33081
50	Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari	Bari		Italy	70124
51	University of Bologna	Bologna		Italy	40126
52	Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori	Meldola		Italy	47014
53	Ospedale San Raffaele	Milano		Italy	20132
54	Fondazione Irccs Istituto Nazionale Dei Tumori	Milano		Italy	20133
55	A.O.U. Di Modena - Policlinico	Modena		Italy	41124
56	A.O.U. Federico Ii	Napoli		Italy	80131
57	Aou Maggiore Della Carita	Novara		Italy	28100
58	Ospedali Riuniti Villa Sofia Cervello	Palermo		Italy	90146
59	Sapienza University	Rome		Italy	00161
60	I.R.C.C.S. Casa Sollievo Della Sofferenza	San Giovanni Rotondo		Italy	71013
61	Aou Citta Della Salute E Della Scienza Di Torino	Torino		Italy	10126
62	San Bartolo Hospital	Vicenza		Italy	36100
63	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland	80-952
64	Pratia McM Krakow	Krakow		Poland	30-510
65	State Hospital Opole	Opole		Poland	45-372
66	Institute of Hematology and Transfusion Medicine	Warszawa		Poland	02-776
67	Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie	Warszawa		Poland	02-781
68	Hospital de La Santa Creu I Sant Pau	Barcelona		Spain	08026
69	Hospital General Universitari Vall D Hebron	Barcelona		Spain	08035
70	Hgu Gregorio Maranon	Madrid		Spain	28009
71	Md Anderson Cancer Centre Madrid	Madrid		Spain	28033
72	Hospital Universitario Ramon Y Cajal	Madrid		Spain	28034
73	Hospital Universitario de La Paz	Madrid		Spain	28046
74	Hospital Universitario Hm Sanchinarro	Madrid		Spain	28050
75	Hospital Universitario Quironsalud Madrid	Madrid		Spain	28223
76	Hospital Universitario de Canarias	San Cristobal de La Laguna		Spain	38320
77	Hospital Universitario Virgen Macarena	Sevilla		Spain	41007
78	Hospital Universitario Virgen Del Rocio	Sevilla		Spain	41013
79	Karolinska University Hospital, Huddinge	Stockholm		Sweden	14141
80	Birmingham Heartlands Hospital	Birmingham		United Kingdom	B9 5SS
81	Northwick Park Hospital	London		United Kingdom	SE5 9RS
82	Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF
83	The Royal Marsden Nhs Foundation Trust - Chelsea	Sutton		United Kingdom	SM2 5PT

Sponsors and Collaborators

• Incyte Corporation

Investigators

• Study Director: Fred Zheng, MD, PhD, Incyte Corporation

Study Documents (Full-Text)

• Study Protocol - Dec 23, 2019
• Statistical Analysis Plan - Jan 28, 2021

More Information

Publications

None provided.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT03126019
• Other Study ID Numbers: INCB 50465-203 (CITADEL-203); Parsaclisib; 2017-001624-22
• First Posted: Apr 24, 2017
• Last Update Posted: Jul 14, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Incyte Corporation: Follicular lymphoma; non-Hodgkin lymphoma (NHL); phosphatidylinositol 3-kinase (PI3K) δ inhibitor
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 44 investigative sites in the United States, Italy, Spain, Great Britain, Czech Republic, Hungary, Canada, Denmark, Germany, Israel, Poland, and Sweden from 14 March 2018 and are planned to continue in the study till 31 March 2023. Data is reported up to primary completion date 15 January 2021. This study is ongoing.
Pre-assignment Detail	A total of 126 participants with relapsed or refractory follicular lymphoma were enrolled in the study and assigned to one of the two treatment groups: Treatment A or Treatment B to receive parsaclisib.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Period Title: Overall Study
STARTED	23	103
COMPLETED	0	0
NOT COMPLETED	23	103

Baseline Characteristics

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD	Total
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.	Total of all reporting groups
Overall Participants	23	103	126
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.1 (11.56)	67.0 (10.68)	66.5 (10.86)
Sex: Female, Male (Count of Participants)
Female	11 47.8%	45 43.7%	56 44.4%
Male	12 52.2%	58 56.3%	70 55.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.3%	6 5.8%	7 5.6%
Not Hispanic or Latino	19 82.6%	90 87.4%	109 86.5%
Unknown or Not Reported	3 13%	7 6.8%	10 7.9%
Race Customized (Count of Participants)
Asian	0 0%	1 1%	1 0.8%
Black/ African- American	1 4.3%	6 5.8%	7 5.6%
White/ Caucasian	21 91.3%	92 89.3%	113 89.7%
Other	1 4.3%	4 3.9%	5 4%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
Description	ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions.
Time Frame	Up to approximately 148 weeks

Outcome Measure Data

Analysis Population Description

FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Measure Participants	23	103
Number (95% Confidence Interval) [percentage of participants]	65.2 283.5%	77.7 75.4%

2. Secondary Outcome

Title	Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
Description	CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas as determined by an IRC. The criteria for CR included: 1. Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3. Organ enlargement regressed to normal; 4. No new lesions; 5. Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
Time Frame	Up to approximately 148 weeks

Outcome Measure Data

Analysis Population Description

FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Measure Participants	23	103
Number (95% Confidence Interval) [percentage of participants]	13.0 56.5%	19.4 18.8%

3. Secondary Outcome

Title	Duration of Response (DOR)
Description	DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.
Time Frame	Up to approximately 148 weeks

Outcome Measure Data

Analysis Population Description

FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed for this outcome measure.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Measure Participants	15	80
Median (95% Confidence Interval) [months]	14.06	14.72

4. Secondary Outcome

Title	Progression-free Survival (PFS) With Parsaclisib
Description	PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.
Time Frame	Up to approximately 148 weeks

Outcome Measure Data

Analysis Population Description

FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Measure Participants	23	103
Median (95% Confidence Interval) [months]	13.90	15.80

5. Secondary Outcome

Title	Overall Survival (OS) With Parsaclisib
Description	OS was defined as the time from the date of the first dose of study treatment until death from any cause.
Time Frame	Up to approximately 148 weeks

Outcome Measure Data

Analysis Population Description

FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Measure Participants	23	103
Median (95% Confidence Interval) [months]	NA	NA

6. Secondary Outcome

Title	Best Percent Change From Baseline in Target Lesion Size
Description	Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
Time Frame	Up to approximately 148 weeks

Outcome Measure Data

Analysis Population Description

The FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Overall number analyzed are the number of participants with data available for analyses.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Measure Participants	20	99
Mean (Standard Deviation) [percent change in lesion size]	-72.01 (21.673)	-71.04 (31.357)

7. Secondary Outcome

Title	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description	An adverse event (AE) is defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
Time Frame	From first dose of study drug up to approximately 148 weeks

Outcome Measure Data

Analysis Population Description

Safety Population included all participants enrolled in the study who received at least 1 dose of parsaclisib.

Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW	Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.	Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Measure Participants	23	103
TEAEs	100.0 434.8%	97.1 94.3%
SAEs	43.5 189.1%	45.6 44.3%

Adverse Events

Time Frame	From first dose of study drug up to approximately 148 weeks
Adverse Event Reporting Description	Safety Population included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Arm/Group Title	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW		Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD		Total
Arm/Group Description	Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.		Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.		Total
All Cause Mortality
	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW		Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/23 (8.7%)		7/103 (6.8%)		9/126 (7.1%)
Serious Adverse Events
	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW		Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/23 (43.5%)		47/103 (45.6%)		57/126 (45.2%)
Blood and lymphatic system disorders
Anaemia	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Febrile neutropenia	0/23 (0%)	0	2/103 (1.9%)	2	2/126 (1.6%)	2
Leukocytosis	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Cardiac disorders
Atrial fibrillation	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Pericardial effusion	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Supraventricular tachycardia	0/23 (0%)	0	1/103 (1%)	2	1/126 (0.8%)	2
Ear and labyrinth disorders
Vertigo	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Gastrointestinal disorders
Colitis	0/23 (0%)	0	8/103 (7.8%)	8	8/126 (6.3%)	8
Colitis erosive	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Diarrhoea	0/23 (0%)	0	9/103 (8.7%)	10	9/126 (7.1%)	10
Diverticular perforation	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Immune-mediated enterocolitis	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Intestinal pseudo-obstruction	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Oesophagitis	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Parotid gland enlargement	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Small intestinal obstruction	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Vomiting	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
General disorders
Chest pain	0/23 (0%)	0	2/103 (1.9%)	3	2/126 (1.6%)	3
Mucosal inflammation	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Non-cardiac chest pain	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Pyrexia	0/23 (0%)	0	2/103 (1.9%)	2	2/126 (1.6%)	2
Infections and infestations
Bacteraemia	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Bursitis infective	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Campylobacter colitis	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Coronavirus infection	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Cytomegalovirus colitis	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Gastrointestinal infection	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Herpes zoster	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Influenza	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Lower respiratory tract infection	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Lower respiratory tract infection viral	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Oesophageal candidiasis	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Oral candidiasis	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Pneumocystis jirovecii pneumonia	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Pneumonia	0/23 (0%)	0	2/103 (1.9%)	3	2/126 (1.6%)	3
Pneumonia mycoplasmal	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Respiratory tract infection	1/23 (4.3%)	1	1/103 (1%)	1	2/126 (1.6%)	2
Subcutaneous abscess	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Urinary tract infection	0/23 (0%)	0	2/103 (1.9%)	2	2/126 (1.6%)	2
Urosepsis	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Injury, poisoning and procedural complications
Cervical vertebral fracture	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Fall	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Hip fracture	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Overdose	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Wrist fracture	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Investigations
Body temperature increased	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
C-reactive protein increased	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Electrocardiogram QT prolonged	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Neutrophil count decreased	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Metabolism and nutrition disorders
Dehydration	1/23 (4.3%)	1	1/103 (1%)	1	2/126 (1.6%)	2
Hypercalcaemia	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Hyperglycaemia	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Hyperkalaemia	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Hypokalaemia	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Arthritis	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Autoimmune arthritis	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Back pain	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Musculoskeletal chest pain	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Neck pain	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoplastic mesothelioma	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Lung neoplasm malignant	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Nervous system disorders
Cervical radiculopathy	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Dizziness	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Encephalopathy	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Headache	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Lacunar infarction	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Lethargy	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Nervous system disorder	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Renal and urinary disorders
Acute kidney injury	1/23 (4.3%)	1	1/103 (1%)	1	2/126 (1.6%)	2
Urinary tract obstruction	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Pleural effusion	0/23 (0%)	0	2/103 (1.9%)	5	2/126 (1.6%)	5
Pneumonitis	1/23 (4.3%)	1	2/103 (1.9%)	2	3/126 (2.4%)	3
Pneumothorax	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Rash	0/23 (0%)	0	2/103 (1.9%)	2	2/126 (1.6%)	2
Stevens-Johnson syndrome	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Vascular disorders
Deep vein thrombosis	0/23 (0%)	0	1/103 (1%)	1	1/126 (0.8%)	1
Haemorrhage	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Hypotension	1/23 (4.3%)	1	0/103 (0%)	0	1/126 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW		Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/23 (91.3%)		91/103 (88.3%)		112/126 (88.9%)
Blood and lymphatic system disorders
Anaemia	2/23 (8.7%)	2	6/103 (5.8%)	6	8/126 (6.3%)	8
Neutropenia	2/23 (8.7%)	4	16/103 (15.5%)	20	18/126 (14.3%)	24
Cardiac disorders
Extrasystoles	2/23 (8.7%)	2	0/103 (0%)	0	2/126 (1.6%)	2
Gastrointestinal disorders
Abdominal pain	0/23 (0%)	0	8/103 (7.8%)	10	8/126 (6.3%)	10
Constipation	1/23 (4.3%)	1	6/103 (5.8%)	6	7/126 (5.6%)	7
Diarrhoea	3/23 (13%)	5	40/103 (38.8%)	61	43/126 (34.1%)	66
Nausea	6/23 (26.1%)	6	25/103 (24.3%)	29	31/126 (24.6%)	35
Vomiting	3/23 (13%)	4	7/103 (6.8%)	8	10/126 (7.9%)	12
General disorders
Asthenia	2/23 (8.7%)	2	14/103 (13.6%)	17	16/126 (12.7%)	19
Fatigue	3/23 (13%)	3	19/103 (18.4%)	21	22/126 (17.5%)	24
Oedema peripheral	1/23 (4.3%)	1	9/103 (8.7%)	9	10/126 (7.9%)	10
Peripheral swelling	2/23 (8.7%)	2	1/103 (1%)	1	3/126 (2.4%)	3
Pyrexia	2/23 (8.7%)	2	18/103 (17.5%)	24	20/126 (15.9%)	26
Infections and infestations
Upper respiratory tract infection	3/23 (13%)	4	6/103 (5.8%)	6	9/126 (7.1%)	10
Urinary tract infection	3/23 (13%)	3	4/103 (3.9%)	4	7/126 (5.6%)	7
Investigations
Alanine aminotransferase increased	1/23 (4.3%)	1	7/103 (6.8%)	11	8/126 (6.3%)	12
Aspartate aminotransferase increased	1/23 (4.3%)	1	7/103 (6.8%)	8	8/126 (6.3%)	9
C-reactive protein increased	2/23 (8.7%)	2	2/103 (1.9%)	2	4/126 (3.2%)	4
Weight decreased	0/23 (0%)	0	6/103 (5.8%)	6	6/126 (4.8%)	6
Metabolism and nutrition disorders
Decreased appetite	1/23 (4.3%)	1	8/103 (7.8%)	8	9/126 (7.1%)	9
Hyperglycaemia	1/23 (4.3%)	2	7/103 (6.8%)	8	8/126 (6.3%)	10
Hypokalaemia	0/23 (0%)	0	11/103 (10.7%)	14	11/126 (8.7%)	14
Hypomagnesaemia	0/23 (0%)	0	9/103 (8.7%)	10	9/126 (7.1%)	10
Musculoskeletal and connective tissue disorders
Arthralgia	2/23 (8.7%)	3	10/103 (9.7%)	10	12/126 (9.5%)	13
Back pain	1/23 (4.3%)	1	8/103 (7.8%)	8	9/126 (7.1%)	9
Myalgia	2/23 (8.7%)	2	5/103 (4.9%)	5	7/126 (5.6%)	7
Pain in extremity	1/23 (4.3%)	1	7/103 (6.8%)	7	8/126 (6.3%)	8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm	2/23 (8.7%)	2	0/103 (0%)	0	2/126 (1.6%)	2
Nervous system disorders
Dizziness	1/23 (4.3%)	1	6/103 (5.8%)	6	7/126 (5.6%)	7
Headache	1/23 (4.3%)	1	9/103 (8.7%)	9	10/126 (7.9%)	10
Respiratory, thoracic and mediastinal disorders
Cough	3/23 (13%)	3	25/103 (24.3%)	26	28/126 (22.2%)	29
Dyspnoea	0/23 (0%)	0	6/103 (5.8%)	6	6/126 (4.8%)	6
Oropharyngeal pain	2/23 (8.7%)	2	4/103 (3.9%)	4	6/126 (4.8%)	6
Wheezing	2/23 (8.7%)	2	0/103 (0%)	0	2/126 (1.6%)	2
Skin and subcutaneous tissue disorders
Pruritus	4/23 (17.4%)	6	2/103 (1.9%)	2	6/126 (4.8%)	8
Rash	6/23 (26.1%)	8	12/103 (11.7%)	15	18/126 (14.3%)	23
Vascular disorders
Hypertension	0/23 (0%)	0	10/103 (9.7%)	10	10/126 (7.9%)	10

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.