Trial Outcomes & Findings for A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) (NCT NCT03144674)

Last Updated: 2025-07-11

Results Overview

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),assign 5mm×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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

110 participants

Primary outcome timeframe

Up to approximately 161 weeks

Results posted on

2025-07-11

Participant Flow

This study enrolled participants at 46 study centers in the United States, Italy, Israel, France, Spain, Poland, Belgium, Great Britain, and Germany.

A total of 110 participants diagnosed with relapsed or refractory marginal zone lymphoma were enrolled into two cohorts based on previous treatment with ibrutinib as Cohort 1: those who were exposed to ibrutinib before enrollment and Cohort 2: those who were not exposed to Bruton's tyrosine kinase (BTK) inhibitor before enrollment. Participants were further allocated to Treatments A and B in each Cohort to receive parsaclisib.

Participant milestones

Participant milestones
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Overall Study STARTED	4	6	28	72
Overall Study COMPLETED	0	2	13	26
Overall Study NOT COMPLETED	4	4	15	46

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Overall Study Participant Transferred to Rollover Study	1	1	5	6
Overall Study Death	3	2	6	24
Overall Study Lost to Follow-up	0	1	0	4
Overall Study Withdrawal by Participant	0	0	2	6
Overall Study Discharged from the Trust	0	0	1	0
Overall Study Exclusion Criteria Met	0	0	1	0
Overall Study Changed Physicians	0	0	0	1
Overall Study Removed for Safety	0	0	0	1
Overall Study Site Closed	0	0	0	1
Overall Study Histological Criteria Not Met	0	0	0	1
Overall Study Multifactorial Cognitive Decline	0	0	0	1
Overall Study Progression of Chronic Lymphocytic Leukemia	0	0	0	1

Baseline Characteristics

A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=4 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=6 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=28 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=72 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Total n=110 Participants Total of all reporting groups
Age, Continuous	73.5 years n=5 Participants	72.2 years n=7 Participants	68.1 years n=5 Participants	69.8 years n=4 Participants	69.6 years n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants	31 Participants n=4 Participants	53 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants	41 Participants n=4 Participants	57 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants	57 Participants n=4 Participants	83 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	23 Participants n=5 Participants	60 Participants n=4 Participants	91 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants	16 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to approximately 161 weeks

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=4 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=6 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=28 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=72 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Objective Response Rate (ORR) Based on Lugano Classification Criteria	50.0 percentage of participants Interval 6.8 to 93.2	33.3 percentage of participants Interval 4.3 to 77.7	57.1 percentage of participants Interval 37.2 to 75.5	58.3 percentage of participants Interval 46.1 to 69.8

SECONDARY outcome

Timeframe: Up to 1305 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=2 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=2 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=17 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=41 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Duration of Response (DOR)	NA months The median and lower and upper limits of the 95% confidence interval (CI) were not estimable due to the low number of participants with events of response.	NA months The median and lower and upper limits of the 95% CI were not estimable due to the low number of participants with events of response.	16.69 months Interval 3.71 to The upper limit of the 95% CI was not estimable due to the low number of participants with events of response.	13.57 months Interval 8.05 to 17.74

SECONDARY outcome

Timeframe: Up to 1305 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

CRR is defined as the percentage of participants with a CR 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=4 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=6 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=28 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=72 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Complete Response Rate (CRR) Based on Lugano Classification Criteria	0.0 percentage of participants Interval 0.0 to 60.2	0.0 percentage of participants Interval 0.0 to 45.9	10.7 percentage of participants Interval 2.3 to 28.2	4.2 percentage of participants Interval 0.9 to 11.7

SECONDARY outcome

Timeframe: Up to 1305 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

PFS is 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=4 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=6 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=28 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=72 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Progression-Free Survival (PFS)	NA months The median and lower and upper limits of the 95% CI were not estimable due to the low number of participants with events.	NA months The median and lower and upper limits of the 95% CI were not estimable due to the low number of participants with events.	19.42 months Interval 8.77 to The upper limit of the 95% CI was not estimable due to the low number of participants with events.	17.74 months Interval 11.53 to 22.34

SECONDARY outcome

Timeframe: Up to 2354 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib

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

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=4 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=6 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=28 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=72 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Overall Survival (OS)	18.94 months Interval 7.26 to The upper limit of the 95% CI was not estimable due to the low number of participants with events.	NA months Interval 3.22 to The median was not reached and the upper limit of the 95% CI was not estimable due to the low number of participants with events.	NA months Interval 59.6 to The median was not reached and the upper limit of the 95% CI was not estimable due to the low number of participants with events.	63.54 months Interval 39.72 to The median was not reached and the upper limit of the 95% CI was not estimable due to the low number of participants with events.

SECONDARY outcome

Timeframe: Up to 1305 days

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. The overall number of participants analyzed is the number of participants with splenomegaly and data available for analysis.

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 nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=4 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=5 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=20 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=51 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Best Percent Change From Baseline in Target Lesion Size	-48.83 percent change in lesion size Standard Deviation 21.193	-54.84 percent change in lesion size Standard Deviation 21.454	-71.22 percent change in lesion size Standard Deviation 18.566	-66.76 percent change in lesion size Standard Deviation 19.971

SECONDARY outcome

Timeframe: From first dose of study drug up to 1980 days

Population: Safety Population: all enrolled participants who received at least 1 dose of parsaclisib

An adverse event (AE) is 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. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment A (Exposed to Ibrutinib) n=4 Participants Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 1: Treatment B (Exposed to Ibrutinib) n=6 Participants Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.	Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) n=28 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.	Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) n=72 Participants Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	100.0 percentage of participants	83.3 percentage of participants	92.9 percentage of participants	97.2 percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	50.0 percentage of participants	33.3 percentage of participants	32.1 percentage of participants	63.9 percentage of participants

Adverse Events

Cohort 1: Treatment A (Exposed to Ibrutinib)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Cohort 1: Treatment B (Exposed to Ibrutinib)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)

Serious events: 9 serious events

Other events: 25 other events

Deaths: 6 deaths

Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)

Serious events: 46 serious events

Other events: 67 other events

Deaths: 25 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER