LymphomaPhase 2NCT02998476

A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

A Phase 2 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 70 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma
What is being tested?: Parsaclisib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 70 sitesin 11 countries
Study dates: 2 Mar 2017to 5 Feb 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eligible 19 years and older in South Korea
Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
Eastern Cooperative Oncology Group performance status 0 to 2.

Who cannot join

Primary mediastinal (thymic) large B-cell lymphoma.
Known brain or central nervous system metastases or history of uncontrolled seizures.
Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
Prior treatment with the following:
Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.

Trial locations and contacts

70 sites in 11 countries.

Country

City, postcode or hospital

70 sites in 11 countries

United States20 sites

Abington Memorial Hospital
Abington, Pennsylvania, 19001
St. Agnes Hospital
Baltimore, Maryland, 21229
Indiana BMT
Beech Grove, Indiana, 46107
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Karmanos Cancer Institute
Detroit, Michigan, 48201
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Parkview Research Center
Fort Wayne, Indiana, 46845
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
CHI Health - St. Francis Medical Center
Grand Island, Nebraska, 68802
Clinical Research Alliance
Lake Success, New York, 11042
University of Kentucky Hospital
Lexington, Kentucky, 40536-0298
Advanced Pharma CR, LLC
Miami, Florida, 33147
Sutter Gould Medical Foundation
Modesto, California, 95355
Summit Medical Group
Morristown, New Jersey, 07960
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901-1914
Advocate Medical Group Niles Milwaukee Ave
Niles, Illinois, 60714
Utah Cancer Specialists- Network
Salt Lake City, Utah, 84106
Sharp Memorial Hospital
San Diego, California, 92123
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, 85284
Asclepes Research Centers
Weeki Wachee, Florida, 34607

Other trials in United States

France14 sites

Centre Hospitalier d'Angers
Angers, Maine Et Loire, 49033
Centre Francois Baclesse
Caen, Calvados, 14076
Hôpital Henri Mondor
Créteil, Val De Marne, 94010
CHU Dijon - Hopital du Bocage
Dijon, Cote dÝOr, 21079
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, Isere, 38043
Chu de Grenoble - Hopital Albert Michallon
Grenoble, 38043
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sarthe, 72015
Centre Hospitalier Libourne
Libourne, Gironde, 33505
Hopital Claude Huriez - CHU Lille
Lille, Nord, 59037
Centre Antoine Lacassagne
Nice, Alpes Maritimes, 06189
Hôpital Saint-Louis
Paris, Paris, 75475
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
Chu Vandoeuvre-Les-Nancy Hopital Brabois
Vandœuvre-lès-Nancy, 54500
Institut Gustave Roussy
Villejuif, 94805

Other trials in France

Spain7 sites

Hospital del Mar
Barcelona, 08003
ICO l´Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, 28034
Clinica Universidad de Navarra (Cun)
Pamplona, 31008
Hospital Universitario Nuestra Señora de Valme
Seville, 41014
Hospital Txagorritxu
Vitoria-Gasteiz, 01009

Other trials in Spain

Australia6 sites

Ballarat Base Hospital
Ballarat, Victoria, 3350
Flinders Medical Centre
Bedford Park, South Australia, 5042
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Sunshine Hospital
St Albans, Victoria, 3021
Westmead Hospital
Westmead, New South Wales, 2145

Other trials in Australia

Belgium4 sites

ZNA Stuivenberg
Antwerp, 2060
Cliniques Universitaires Ucl Saint-Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
AZ Delta
Roeselare, 8800

Other trials in Belgium

Czechia4 sites

Fakultni nemocnice Brno
Brno, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
University Hospital Ostrava
Ostrava, 70852
Fakultni nemocnice v Motole
Prague, 15000

Other trials in Czechia

Italy4 sites

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, 70124
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, 47014
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

South Korea4 sites

Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351

Other trials in South Korea

Poland3 sites

Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, 36-200
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Malopolskie Centrum Medyczne s.c.
Krakow, 30-510

Other trials in Poland

United Kingdom3 sites

The Christie
Manchester, Greater Manchester, M20 4BX
Southend University Hospital
Southend-on-Sea, SS0 ORY
Royal Marsden Hospital
Sutton, SM2 5PT

Other trials in United Kingdom

Canada1 site

LHSC - Victoria Hospital
London, Ontario, N6A 5W9

Other trials in Canada

About this study

Official title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Conditions: Lymphoma
Being tested: Parsaclisib
Keywords: Diffuse large B-cell lymphoma, relapsed, refractory, non-Hodgkin lymphoma, phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor, Bruton's tyrosine kinase (BTK)
Medical subject headings: Lymphoma, Lymphoma, Large B-Cell, Diffuse, Recurrence, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ParsaclisibDrug
Also called INCB050465
Parsaclisib once daily for 8 weeks followed by once weekly

Study groups in NCT02998476
Study group	Role	What they receive
Group A Parsaclisib (no prior BTK inhibitor)	Experimental	Parsaclisib in subjects who were not previously treated with a BTK inhibitor. Receives: Drug: Parsaclisib
Group B Parsaclisib (prior BTK inhibitor)	Experimental	Parsaclisib in subjects who were previously treated with a BTK inhibitor. Receives: Drug: Parsaclisib

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate Based on Lugano Classification Criteria in Group A
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
Measured: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

Secondary outcomes (4)

Duration of Response in Group A
Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.
Measured: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Progression-free Survival in Group A
Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.
Measured: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Overall Survival (OS) in Group A
Defined as the time from the date of the first dose of study drug until death by any cause.
Measured: From first dose of study drug until death by any cause; up to 26 months
Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.
Measured: Screening through 35 days after end of treatment, up to 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20175 Feb 2021

First posted20 Dec 2016 (estimated)
Study start2 Mar 2017
Primary completion22 Feb 2019
Study completion5 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LymphomaStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02998476
Sponsor's protocol ID: INCB 50465-202/CITADEL-202
Other IDs: Parsaclisib, 2016-002205-19, 2016
Status last verified: Aug 2025
First submitted: 13 Dec 2016
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Coleman M, Belada D, Casasnovas RO, Gressin R, Lee HP, Mehta A, Munoz J, Verhoef G, Corrado C, DeMarini DJ, Zhao W, Li J, Fay K. Phase 2 study of parsaclisib (INCB050465), a highly selective, next-generation PI3Kdelta inhibitor, in relapsed or refractory diffuse large B-cell lymphoma (CITADEL-202). Leuk Lymphoma. 2021 Feb;62(2):368-376. doi: 10.1080/10428194.2020.1832660. Epub 2020 Nov 3.
PubMed 33140664

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
ClinicalTrials.gov ID: NCT02998476
Acronym / sponsor ID: INCB 50465-202/CITADEL-202
Conditions: Lymphoma
Keywords: Diffuse large B-cell lymphoma, relapsed, refractory, non-Hodgkin lymphoma, phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor, Bruton's tyrosine kinase (BTK)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 2 Mar 2017 (actual)
Primary completion: 22 Feb 2019 (actual)
Study completion: 5 Feb 2021 (actual)
First posted: 20 Dec 2016 (estimated)
Results: Posted 24 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A Parsaclisib (no prior BTK inhibitor)	Experimental	Drug: ParsaclisibParsaclisib in subjects who were not previously treated with a BTK inhibitor.
Group B Parsaclisib (prior BTK inhibitor)	Experimental	Drug: ParsaclisibParsaclisib in subjects who were previously treated with a BTK inhibitor.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Eligible 19 years and older in South Korea
Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
Eastern Cooperative Oncology Group performance status 0 to 2.

Key exclusion criteria (7 listed)

Primary mediastinal (thymic) large B-cell lymphoma.
Known brain or central nervous system metastases or history of uncontrolled seizures.
Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
Prior treatment with the following:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ParsaclisibAlso: INCB050465Parsaclisib once daily for 8 weeks followed by once weekly	Drug	Group A Parsaclisib (no prior BTK inhibitor), Group B Parsaclisib (prior BTK inhibitor)

Primary outcome

Objective Response Rate Based on Lugano Classification Criteria in Group A
Time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.

4 secondary outcomes

Duration of Response in Group A
Time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Progression-free Survival in Group A
Time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Overall Survival (OS) in Group A
Time frame: From first dose of study drug until death by any cause; up to 26 months
Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
Time frame: Screening through 35 days after end of treatment, up to 42 months

Results and safety

Results posted to the registry on 24 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A Parsaclisib (no Prior BTK Inhibitor)	55	0
Group B Parsaclisib (Prior BTK Inhibitor)	5	0

Primary outcome: Objective Response Rate Based on Lugano Classification Criteria in Group A

Time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months. Number (95% Confidence Interval). Unit: percentage

Measure	Group A Parsaclisib (no Prior BTK Inhibitor) n = 55
Value	25.5 (14.7 to 39.0)

Population analysed: The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening through 35 days after end of treatment, up to 42 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A Parsaclisib (no Prior BTK Inhibitor)	39 of 55 (70.9%)	41 of 55 (74.5%)	45 of 55
Group B Parsaclisib (Prior BTK Inhibitor)	2 of 5 (40%)	3 of 5 (60%)	3 of 5
Total	41 of 60 (68.3%)	44 of 60 (73.3%)	48 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33140664Coleman M, Belada D, Casasnovas RO, Gressin R, Lee HP, Mehta A, Munoz J, Verhoef G, Corrado C, DeMarini DJ, Zhao W, Li J, Fay K. Phase 2 study of parsaclisib (INCB050465), a highly selective, next-generation PI3Kdelta inhibitor, in relapsed or refractory diffuse large B-cell lymphoma (CITADEL-202). Leuk Lymphoma. 2021 Feb;62(2):368-376. doi: 10.1080/10428194.2020.1832660. Epub 2020 Nov 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claudia Corrado, MD study director

Incyte Corporation

70 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 70 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, France, Spain, Australia, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate Based on Lugano Classification Criteria in Group A (time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998476, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.