A Study Evaluating Safety, PK, and Efficacy of Tafasitama... | NCT04809467

NCT04809467

ID	Type	Description	Link
2020-005591-35	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tafasitamab + parsaclisib	Experimental	Participants will be assigned to disease specific cohorts based on the histology of their underlying disease. Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL	Drug: tafasitamab Drug: parsaclisib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tafasitamab	Drug	tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.	tafasitamab + parsaclisib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Any Treatment-emergent Adverse Event (TEAE )	An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug.	up to 1092 days
Number of Participants With Any ≥Grade 3 TEAE	An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.	up to 1092 days
Number of Participants With Dose-limiting Toxicities (DLTs)	A DLT was defined as the occurrence of any protocol-defined toxicity up to and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation.	up to 28 days
Objective Response Rate Based on Investigator Assessment: Percentage of Participants With CR/CMR or PR/PMR According to Lugano Criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) Criteria for CLL

Secondary Outcomes

Measure	Description	Time Frame
Cmax of Tafasitamab When Given in Combination With Parsaclisib	Cmax was defined as the maximum observed plasma or serum concentration of tafasitamab.	Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
Tmax of Tafasitamab When Given in Combination With Parsaclisib

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Oliver Manzke, MD	Incyte Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama At Birmingham Comprehensive Cancer Center		Birmingham	Alabama	35205	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: R/R DLBCL	Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 13, 2022	Oct 21, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Lugano complete response/complete metabolic response (CR/CMR): target nodes/masses of lymph nodes/extralymphatic sites (LNs/ELSs) regressed to ≤1.5 cm; no non-measured lesions; organ enlargement regressed to normal; no new lesions (NNLs); normal bone marrow. Lugano partial response/partial metabolic response (PR/PMR): LNs/ELSs, ≥50% decrease in the product of perpendicular diameters sum for multiple lesions; no/regressed non-measured lesions, no increase; organ enlargement; NNLs. iwCLL CR: no LNs ≥1.5 cm; spleen size <13 cm/liver size normal; no constitutional symptoms; normal circulating lymphocyte count (CLC); ≥100 × 10^9 platelets/L; hemoglobin ≥11 g/dL; normocellular, no CLL cells, no B-lymphoid nodules in marrow. iwCLL PR decrease of ≥50% in lymph nodes, liver and/or spleen, and CLC from baseline; constitutional symptoms; ≥100 × 10^9 platelets/L or increase of ≥50% over baseline in platelet count and hemoglobin; presence of CLL cells, or of B-lymphoid nodules, or not done.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: R/R DLBCL	Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
BG001	Cohort 2: R/R MCL	Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
BG002	Cohort 3: R/R FL	Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
BG003	Cohort 4: R/R MZL	Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
BG004	Cohort 5: R/R CLL/SLL	Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00067.2± 15.47 BG00168.9± 15.06 BG00266.8± 8.03 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0005 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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 Participants With Any Treatment-emergent Adverse Event (TEAE )

An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug.

Full Analysis Set: all participants who received at least 1 dose of tafasitamab or parsaclisib

Posted

Count of Participants

Participants

up to 1092 days

ID	Title	Description
OG000	Cohort 1: R/R DLBCL	Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
OG001	Cohort 2: R/R MCL	Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
OG002	Cohort 3: R/R FL	Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
OG003	Cohort 4: R/R MZL	Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
OG004	Cohort 5: R/R CLL/SLL	Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG00015 OG00111 OG00221 OG003

Title

Denominators

Categories

Title	Measurements
	OG00015 OG00111 OG00221 OG003

Primary

Number of Participants With Any ≥Grade 3 TEAE

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

Full Analysis Set

Posted

Count of Participants

Participants

up to 1092 days

ID	Title	Description
OG000	Cohort 1: R/R DLBCL	Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Primary

Number of Participants With Dose-limiting Toxicities (DLTs)

A DLT was defined as the occurrence of any protocol-defined toxicity up to and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation.

Dose-limiting Toxicity Evaluable Population: all participants who received at least 3 of 4 doses of tafasitamab and 21 days of treatment with parsaclisib 20 mg QD during the first cycle (28 days) or experienced a DLT

Posted

Count of Participants

Participants

up to 28 days

ID	Title	Description
OG000	Cohort 1: R/R DLBCL	Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
OG001	Cohort 2: R/R MCL	Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Primary

Objective Response Rate Based on Investigator Assessment: Percentage of Participants With CR/CMR or PR/PMR According to Lugano Criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) Criteria for CLL

Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.

Posted

Number

95% Confidence Interval

percentage of participants

up to 1002 days

ID	Title	Description
OG000	Cohort 1: R/R DLBCL	Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Secondary

Cmax of Tafasitamab When Given in Combination With Parsaclisib

Cmax was defined as the maximum observed plasma or serum concentration of tafasitamab.

Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of tafasitamab or parsaclisib and provided at least 1 postdose PK plasma sample. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

milligrams per liter (mg/L)

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

Tmax of Tafasitamab When Given in Combination With Parsaclisib

tmax was defined as the time to the maximum concentration of tafasitamab.

PK Population. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

hours

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

AUClast of Tafasitamab When Given in Combination With Parsaclisib

AUClast was defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.

PK Population. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

hours x mg/L

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

AUC0-inf of Tafasitamab When Given in Combination With Parsaclisib

AUC0-inf was defined as the area under the plasma concentration-time curve from time zero to infinity (time that the drug is no longer present in the body).

PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

hours x mg/L

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

Clast of Tafasitamab When Given in Combination With Parsaclisib

AUC0-inf was defined as the last measurable plasma drug concentration.

PK Population. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

mg/L

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

t1/2 of Tafasitamab When Given in Combination With Parsaclisib

t1/2 was defined as the drug's elimination half-life, which is the time it takes for the concentration of a drug in the body to decrease by 50%.

PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

hours

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

CL of Tafasitamab When Given in Combination With Parsaclisib

CL was defined as the apparent total body clearance of drug from plasma.

PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

liter per hour

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

VZ of Tafasitamab When Given in Combination With Parsaclisib

Vz was defined as the volume of distribution.

PK Population. Only participants with available data were analyzed. PK is not influenced by different oncology indications; thus, PK data were not analyzed by individual oncology cohorts.

Posted

Mean

Standard Deviation

liters

Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

ID	Title	Description
OG000	All Cohorts	Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: R/R DLBCL	Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.	9	15	6	15	15	15
EG001	Cohort 2: R/R MCL	Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.	7	11	7	11	11	11
EG002	Cohort 3: R/R FL	Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.	4	21	12	21	21	21
EG003	Cohort 4: R/R MZL	Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.	0	3	2	3	3	3
EG004	Cohort 5: R/R CLL/SLL	Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.	1	4	3	4	4	4

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG0030 events0 affected3 at risk EG004
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0014 events4 affected11 at risk EG0020 events0 affected21 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0024 events3 affected21 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Cytomegalovirus colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Device related sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0027 events6 affected21 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected11 at risk EG0020 events0 affected21 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Xerosis	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0022 events2 affected21 at risk EG0030 events0 affected3 at risk EG0040 events0 affected4 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events2 affected15 at risk EG0013 events2 affected11 at risk EG0022 events2 affected21 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected11 at risk EG0022 events2 affected21 at risk EG003
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Amylase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected11 at risk EG0022 events2 affected21 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0015 events4 affected11 at risk EG0022 events2 affected21 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0025 events5 affected21 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected15 at risk EG0016 events3 affected11 at risk EG0027 events6 affected21 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0024 events3 affected21 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected11 at risk EG0022 events2 affected21 at risk EG003
Blood glucose increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0022 events2 affected21 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
C-reactive protein increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected15 at risk EG0012 events1 affected11 at risk EG00210 events8 affected21 at risk EG003
Campylobacter colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Candida infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Cell death	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected11 at risk EG0020 events0 affected21 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events2 affected15 at risk EG0016 events4 affected11 at risk EG0022 events2 affected21 at risk EG003
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0024 events2 affected21 at risk EG003
Cytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0013 events1 affected11 at risk EG0024 events3 affected21 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 events4 affected15 at risk EG0012 events2 affected11 at risk EG00215 events11 affected21 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0023 events2 affected21 at risk EG003
Dry eye	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0023 events2 affected21 at risk EG003
Dysgraphia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0024 events4 affected21 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0022 events2 affected21 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Eosinophil count increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Face oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0022 events2 affected21 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Gastrointestinal hypermotility	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
General physical health deterioration	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Graft versus host disease in liver	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Graft versus host disease in skin	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Haemophilus infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0022 events1 affected21 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0024 events3 affected21 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0025 events5 affected21 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0022 events2 affected21 at risk EG003
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0022 events2 affected21 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events3 affected11 at risk EG0022 events2 affected21 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Lipase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0022 events2 affected21 at risk EG003
Liver function test abnormal	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0022 events2 affected21 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected11 at risk EG0029 events5 affected21 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00012 events7 affected15 at risk EG00111 events6 affected11 at risk EG00219 events11 affected21 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0004 events2 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0012 events2 affected11 at risk EG0024 events3 affected21 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0022 events2 affected21 at risk EG003
POEMS syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Pelvic bone injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0006 events3 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0022 events2 affected21 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0005 events3 affected15 at risk EG0013 events3 affected11 at risk EG0029 events6 affected21 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0024 events4 affected21 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0022 events2 affected21 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Respiratory tract infection bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Skin induration	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0022 events2 affected21 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Testicular oedema	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0020 events0 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0018 events7 affected11 at risk EG0024 events3 affected21 at risk EG003
Tremor	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected11 at risk EG0020 events0 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0014 events2 affected11 at risk EG0022 events2 affected21 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0021 events1 affected21 at risk EG003
Vascular device infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0023 events3 affected21 at risk EG003
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003
Xerophthalmia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected11 at risk EG0020 events0 affected21 at risk EG003
Xerosis	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected11 at risk EG0021 events1 affected21 at risk EG003

The sponsor chose to terminate the study early due to the strategic business decision to discontinue the evaluation of parsaclisib in clinical studies. Participants who continued to receive clinical benefit (in the opinion of the investigator) had the option to transition to a rollover study for continued supply of parsaclisib in combination with tafasitamab (including supply of tafasitamab to those who remained on tafasitamab alone).

Certain Agreements

First MCP Posted Date

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D008228	Lymphoma, Non-Hodgkin
D012008	Recurrence
D007938	Leukemia

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008223	Lymphoma

ID	Term
C000613469	tafasitamab
C000656179	parsaclisib