A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
NCT ID: NCT02998476
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2017-03-02
2021-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A Parsaclisib (no prior BTK inhibitor)
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Group B Parsaclisib (prior BTK inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Interventions
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Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Claudia Corrado, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, United States
Sutter Gould Medical Foundation
Modesto, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Asclepes Research Centers
Weeki Wachee, Florida, United States
Advocate Medical Group Niles Milwaukee Ave
Niles, Illinois, United States
Indiana BMT
Beech Grove, Indiana, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
St. Agnes Hospital
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
CHI Health - St. Francis Medical Center
Grand Island, Nebraska, United States
Summit Medical Group
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Clinical Research Alliance
Lake Success, New York, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Utah Cancer Specialists- Network
Salt Lake City, Utah, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Ballarat Base Hospital
Ballarat, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
ZNA Stuivenberg
Antwerp, , Belgium
Cliniques Universitaires Ucl Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Delta
Roeselare, , Belgium
LHSC - Victoria Hospital
London, Ontario, Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
University Hospital Ostrava
Ostrava, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Centre Antoine Lacassagne
Nice, Alpes Maritimes, France
Centre Francois Baclesse
Caen, Calvados, France
CHU Dijon - Hopital du Bocage
Dijon, Cote dÝOr, France
Centre Hospitalier Libourne
Libourne, Gironde, France
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, Isere, France
Centre Hospitalier d'Angers
Angers, Maine Et Loire, France
Hopital Claude Huriez - CHU Lille
Lille, Nord, France
Hôpital Saint-Louis
Paris, Paris, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sarthe, France
Hôpital Henri Mondor
Créteil, Val De Marne, France
Chu de Grenoble - Hopital Albert Michallon
Grenoble, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Chu Vandoeuvre-Les-Nancy Hopital Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, , Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, , Italy
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Malopolskie Centrum Medyczne s.c.
Krakow, , Poland
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
ICO l´Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital del Mar
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Clinica Universidad de Navarra (Cun)
Pamplona, , Spain
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
The Christie
Manchester, Greater Manchester, United Kingdom
Southend University Hospital
Southend-on-Sea, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Parsaclisib
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002205-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 50465-202/CITADEL-202
Identifier Type: -
Identifier Source: org_study_id
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