Clinical trial NCT02998476: A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Diffuse large B-cell lymphoma
relapsed
refractory
non-Hodgkin lymphoma
phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor
Bruton's tyrosine kinase (BTK)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate Based on Lugano Classification Criteria in Group A
timeFrame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Secondary outcomes:
measure: Duration of Response in Group A
timeFrame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
measure: Progression-free Survival in Group A
timeFrame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
measure: Overall Survival (OS) in Group A
timeFrame: From first dose of study drug until death by any cause; up to 26 months
measure: Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
timeFrame: Screening through 35 days after end of treatment, up to 42 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Tempe
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Modesto
country: United States
facility: Sutter Gould Medical Foundation
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Weeki Wachee
country: United States
facility: Asclepes Research Centers
state: Florida
city: Niles
country: United States
facility: Advocate Medical Group Niles Milwaukee Ave
state: Illinois
city: Beech Grove
country: United States
facility: Indiana BMT
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Grand Island
country: United States
facility: CHI Health - St. Francis Medical Center
state: Nebraska
city: Morristown
country: United States
facility: Summit Medical Group
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists- Network
state: Utah
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Brussels
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: AZ Delta
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Nice cedex 02
country: France
facility: Centre Antoine Lacassagne
state: Alpes Maritimes
city: Caen Cedex 05
country: France
facility: Centre Francois Baclesse
state: Calvados
city: Dijon cedex
country: France
facility: CHU Dijon - Hopital du Bocage
state: Cote dÝOr
city: Libourne Cedex
country: France
facility: Centre Hospitalier Libourne
state: Gironde
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
state: Isere
city: Angers Cedex 01
country: France
facility: Centre Hospitalier d'Angers
state: Maine Et Loire
city: Lille cedex
country: France
facility: Hopital Claude Huriez - CHU Lille
state: Nord
city: Paris cedex 10
country: France
facility: Hôpital Saint-Louis
state: Paris
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
state: Sarthe
city: Créteil Cedex
country: France
facility: Hôpital Henri Mondor
state: Val De Marne
city: Grenoble
country: France
facility: Chu de Grenoble - Hopital Albert Michallon
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Vandoeuvre-les-nancy
country: France
facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne s.c.
city: L'Hospitalet de llobregat
country: Spain
facility: ICO l´Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra (Cun)
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Manchester
country: United Kingdom
facility: The Christie
state: Greater Manchester
city: Southend-on-sea
country: United Kingdom
facility: Southend University Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Incyte Corporation
name: Claudia Corrado, MD
role: STUDY_DIRECTOR
References:
citation: 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.