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

August 20, 2025 updated by: Incyte Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Base Hospital
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Belgium
      • Antwerpen, Belgium, 2060
        • ZNA Stuivenberg
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Ucl Saint-Luc
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • LHSC - Victoria Hospital
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni Nemocnice Brno
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava, Czechia, 70852
        • University Hospital Ostrava
      • Praha 5, Czechia, 15000
        • Fakultni nemocnice v Motole
  • France
      • Grenoble, France, 38043
        • CHU de Grenoble - Hôpital Albert Michallon
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
      • Vandoeuvre-les-nancy, France, 54500
        • Chu Vandoeuvre-Les-Nancy Hopital Brabois
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy
    • Alpes Maritimes
      • Nice cedex 02, Alpes Maritimes, France, 06189
        • Centre Antoine Lacassagne
    • Calvados
      • Caen Cedex 05, Calvados, France, 14076
        • Centre François Baclesse
    • Cote dÝOr
      • Dijon cedex, Cote dÝOr, France, 21079
        • Chu Dijon - Hopital Du Bocage
    • Gironde
      • Libourne Cedex, Gironde, France, 33505
        • Centre hospitalier Libourne
    • Isere
      • Grenoble, Isere, France, 38043
        • CHU de Grenoble - Hôpital Albert Michallon
    • Maine Et Loire
      • Angers Cedex 01, Maine Et Loire, France, 49033
        • Centre Hospitalier D'Angers
    • Nord
      • Lille cedex, Nord, France, 59037
        • Hopital Claude Huriez - CHU Lille
    • Paris
      • Paris cedex 10, Paris, France, 75475
        • Hôpital Saint-Louis
    • Sarthe
      • Le Mans Cedex 02, Sarthe, France, 72015
        • Clinique Victor Hugo - Centre Jean Bernard
    • Val De Marne
      • Créteil Cedex, Val De Marne, France, 94010
        • Hôpital Henri Mondor
  • Italy
      • Bari, Italy, 70124
        • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Rome, Italy, 00168
        • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne s.c.
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra (CUN)
      • Sevilla, Spain, 41014
        • Hospital Universitario Nuestra Señora de Valme
      • Vitoria, Spain, 01009
        • Hospital Txagorritxu
    • Barcelona
      • L'Hospitalet de llobregat, Barcelona, Spain, 08907
        • ICO l´Hospitalet - Hospital Duran i Reynals
  • United Kingdom
      • Southend-on-sea, United Kingdom, SS0 ORY
        • Southend University Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Tempe, Arizona, United States, 85284
        • Arizona Oncology Associates, PC - HAL
    • California
      • Modesto, California, United States, 95355
        • Sutter Gould Medical Foundation
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC
      • Weeki Wachee, Florida, United States, 34607
        • ASCLEPES Research Centers
    • Illinois
      • Niles, Illinois, United States, 60714
        • Advocate Medical Group Niles Milwaukee Ave
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Indiana BMT
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0298
        • University of Kentucky Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68802
        • CHI Health - St. Francis Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Summit Medical Group
      • New Brunswick, New Jersey, United States, 08901-1914
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Lake Success, New York, United States, 11042
        • Clinical Research Alliance
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists- Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A Parsaclisib (no prior BTK inhibitor)
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
Drug: Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Other Names:
  • INCB050465
Experimental: Group B Parsaclisib (prior BTK inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
Drug: Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Other Names:
  • INCB050465

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
Defined as the time from the date of the first dose of study drug until death by any cause.
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
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.
Screening through 35 days after end of treatment, up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Claudia Corrado, MD, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2017

Primary Completion (Actual)

February 22, 2019

Study Completion (Actual)

February 5, 2021

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimated)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 50465-202/CITADEL-202
  • Parsaclisib (Other Identifier: Incyte Corporation)
  • 2016-002205-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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