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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998476
• Other study ID #: INCB 50465-202/CITADEL-202
• Secondary ID: Parsaclisib
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2017
• Est. completion date: February 5, 2021

Study information

• Verified date: February 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 5, 2021
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) d inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).

• Group B: Prior treatment with a selective PI3Kd inhibitor (eg, idelalisib) or a pan PI3K inhibitor.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly

Locations

Country	Name	City	State
Australia	Ballarat Base Hospital	Ballarat	Victoria
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Sunshine Hospital	St Albans	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	Cliniques Universitaires Ucl Saint-Luc	Brussels
Belgium	UZ Leuven	Leuven
Belgium	AZ Delta	Roeselare
Canada	LHSC - Victoria Hospital	London	Ontario
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	University Hospital Ostrava	Ostrava
Czechia	Fakultni nemocnice v Motole	Praha 5
France	Centre Hospitalier d'Angers	Angers Cedex 01	Maine Et Loire
France	Centre Francois Baclesse	Caen Cedex 05	Calvados
France	Hôpital Henri Mondor	Créteil Cedex	Val De Marne
France	CHU Dijon - Hopital du Bocage	Dijon cedex	Cote dÝOr
France	Chu de Grenoble - Hopital Albert Michallon	Grenoble
France	CHU de Grenoble - Hôpital Albert Michallon	Grenoble	Isere
France	Clinique Victor Hugo - Centre Jean Bernard	Le Mans Cedex 02	Sarthe
France	Centre Hospitalier Libourne	Libourne Cedex	Gironde
France	Hopital Claude Huriez - CHU Lille	Lille cedex	Nord
France	Centre Antoine Lacassagne	Nice cedex 02	Alpes Maritimes
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Hôpital Saint-Louis	Paris cedex 10	Paris
France	Chu Vandoeuvre-Les-Nancy Hopital Brabois	Vandoeuvre-les-nancy
France	Institut Gustave Roussy	Villejuif Cedex
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	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Poland	Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozów
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Malopolskie Centrum Medyczne s.c.	Krakow
Spain	Hospital del Mar	Barcelona
Spain	ICO l´Hospitalet - Hospital Duran i Reynals	L'Hospitalet de llobregat	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	Sevilla
Spain	Hospital Txagorritxu	Vitoria
United Kingdom	The Christie	Manchester	Greater Manchester
United Kingdom	Southend University Hospital	Southend-on-sea
United Kingdom	Royal Marsden Hospital	Sutton
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	St. Agnes Hospital	Baltimore	Maryland
United States	Indiana BMT	Beech Grove	Indiana
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	CHI Health - St. Francis Medical Center	Grand Island	Nebraska
United States	Clinical Research Alliance	Lake Success	New York
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Sutter Gould Medical Foundation	Modesto	California
United States	Summit Medical Group	Morristown	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Advocate Medical Group Niles Milwaukee Ave	Niles	Illinois
United States	Utah Cancer Specialists- Network	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	Arizona Oncology Associates, PC - HAL	Tempe	Arizona
United States	Asclepes Research Centers	Weeki Wachee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Italy,  Korea, Republic of,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Secondary	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.	Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Secondary	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.	From first dose of study drug until death by any cause; up to 26 months
Secondary	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.	Screening through 35 days after end of treatment, up to 42 months