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

NCT02998476 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: INCB 50465-202/CITADEL-202Parsaclisib2016-002205-19
• Study Type: interventional
• Target: 60
• Locations: 11 countries
• Sites: 70

Brief 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.

Conditions

Lymphoma

Keywords

Diffuse large B-cell lymphoma; relapsed; refractory; non-Hodgkin lymphoma; phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor; Bruton's tyrosine kinase (BTK)

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

• Progression-free Survival in Group A

  Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

• Overall Survival (OS) in Group A

  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

  Screening through 35 days after end of treatment, up to 42 months

Study Arms (2)

Group A Parsaclisib (no prior BTK inhibitor)

EXPERIMENTAL

Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Drug: Parsaclisib

Group B Parsaclisib (prior BTK inhibitor)

EXPERIMENTAL

Parsaclisib in subjects who were previously treated with a BTK inhibitor.

Drug: Parsaclisib

Interventions

Parsaclisib DRUG

Parsaclisib once daily for 8 weeks followed by once weekly

Also known as: INCB050465

Group A Parsaclisib (no prior BTK inhibitor); Group B Parsaclisib (prior BTK inhibitor)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (70)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, 85284, United States

Location

Sutter Gould Medical Foundation

Modesto, California, 95355, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Asclepes Research Centers

Weeki Wachee, Florida, 34607, United States

Location

Advocate Medical Group Niles Milwaukee Ave

Niles, Illinois, 60714, United States

Location

Indiana BMT

Beech Grove, Indiana, 46107, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

University of Kentucky Hospital

Lexington, Kentucky, 40536-0298, United States

Location

St. Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

CHI Health - St. Francis Medical Center

Grand Island, Nebraska, 68802, United States

Location

Summit Medical Group

Morristown, New Jersey, 07960, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901-1914, United States

Location

Clinical Research Alliance

Lake Success, New York, 11042, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Utah Cancer Specialists- Network

Salt Lake City, Utah, 84106, United States

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Ballarat Base Hospital

Ballarat, Victoria, 3350, Australia

Location

Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

LHSC - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

University Hospital Ostrava

Ostrava, 70852, Czechia

Location

Fakultni nemocnice v Motole

Prague, 15000, Czechia

Location

Centre Antoine Lacassagne

Nice, Alpes Maritimes, 06189, France

Location

Centre Francois Baclesse

Caen, Calvados, 14076, France

Location

CHU Dijon - Hopital du Bocage

Dijon, Cote dÝOr, 21079, France

Location

Centre Hospitalier Libourne

Libourne, Gironde, 33505, France

Location

CHU de Grenoble - Hôpital Albert Michallon

Grenoble, Isere, 38043, France

Location

Centre Hospitalier d'Angers

Angers, Maine Et Loire, 49033, France

Location

Hopital Claude Huriez - CHU Lille

Lille, Nord, 59037, France

Location

Hôpital Saint-Louis

Paris, Paris, 75475, France

Location

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, Sarthe, 72015, France

Location

Hôpital Henri Mondor

Créteil, Val De Marne, 94010, France

Location

Chu de Grenoble - Hopital Albert Michallon

Grenoble, 38043, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Chu Vandoeuvre-Les-Nancy Hopital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari, 70124, Italy

Location

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, 47014, Italy

Location

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, 00168, Italy

Location

Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

Brzozów, 36-200, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Malopolskie Centrum Medyczne s.c.

Krakow, 30-510, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

ICO l´Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Clinica Universidad de Navarra (Cun)

Pamplona, 31008, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, 41014, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, 01009, Spain

Location

The Christie

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Southend University Hospital

Southend-on-Sea, SS0 ORY, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33140664 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Recurrence; Lymphoma, Non-Hodgkin

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Claudia Corrado, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 20, 2016
• Study Start: March 2, 2017
• Primary Completion: February 22, 2019
• Study Completion: February 5, 2021
• Last Updated: August 22, 2025
• Results First Posted: April 24, 2020

Record last verified: 2025-08

Locations

US (20); FR (14); IT (4); AU (6); KR (4); GB (3); CA (1); ES (7); PL (3); BE (4); CZ (4)