Back to resultsA Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Parsaclisib
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Diffuse large B-cell lymphoma, relapsed, refractory, non-Hodgkin lymphoma, phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor, Bruton's tyrosine kinase (BTK)
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.
Sites / Locations
- University of Alabama at Birmingham
- Banner MD Anderson Cancer Center
- Arizona Oncology Associates, PC - HAL
- Sutter Gould Medical Foundation
- Sharp Memorial Hospital
- Advanced Pharma CR, LLC
- Asclepes Research Centers
- Advocate Medical Group Niles Milwaukee Ave
- Indiana BMT
- Parkview Research Center
- University of Kentucky Hospital
- St. Agnes Hospital
- Karmanos Cancer Institute
- St. John Hospital and Medical Center
- CHI Health - St. Francis Medical Center
- Summit Medical Group
- Rutgers Cancer Institute of New Jersey
- Clinical Research Alliance
- Abington Memorial Hospital
- Utah Cancer Specialists- Network
- St Vincent's Hospital Sydney
- Westmead Hospital
- Flinders Medical Centre
- Ballarat Base Hospital
- Sunshine Hospital
- Fiona Stanley Hospital
- ZNA Stuivenberg
- Cliniques Universitaires Ucl Saint-Luc
- UZ Leuven
- AZ Delta
- LHSC - Victoria Hospital
- Fakultni nemocnice Brno
- Fakultni nemocnice Hradec Kralove
- University Hospital Ostrava
- Fakultni nemocnice v Motole
- Centre Antoine Lacassagne
- Centre Francois Baclesse
- CHU Dijon - Hopital du Bocage
- Centre Hospitalier Libourne
- CHU de Grenoble - Hôpital Albert Michallon
- Centre Hospitalier d'Angers
- Hopital Claude Huriez - CHU Lille
- Hôpital Saint-Louis
- Clinique Victor Hugo - Centre Jean Bernard
- Hôpital Henri Mondor
- Chu de Grenoble - Hopital Albert Michallon
- Groupe Hospitalier Pitie-Salpetriere
- Chu Vandoeuvre-Les-Nancy Hopital Brabois
- Institut Gustave Roussy
- IRCCS Ospedale Casa Sollievo della Sofferenza
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
- Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
- Seoul National University Hospital
- Severance Hospital, Yonsei University
- Asan Medical Center
- Samsung Medical Center
- Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Uniwersyteckie Centrum Kliniczne
- Malopolskie Centrum Medyczne s.c.
- ICO l´Hospitalet - Hospital Duran i Reynals
- Hospital del Mar
- Hospital General Universitario Gregorio Marañon
- Hospital Universitario Ramon y Cajal
- Clinica Universidad de Navarra (Cun)
- Hospital Universitario Nuestra Señora de Valme
- Hospital Txagorritxu
- The Christie
- Southend University Hospital
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A Parsaclisib (no prior BTK inhibitor)
Group B Parsaclisib (prior BTK inhibitor)
Arm Description
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02998476
First Posted
December 13, 2016
Last Updated
February 28, 2022
Sponsor
Incyte Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02998476
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
February 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Diffuse large B-cell lymphoma, relapsed, refractory, non-Hodgkin lymphoma, phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor, Bruton's tyrosine kinase (BTK)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A Parsaclisib (no prior BTK inhibitor)
Arm Type
Experimental
Arm Description
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
Arm Title
Group B Parsaclisib (prior BTK inhibitor)
Arm Type
Experimental
Arm Description
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
Intervention Type
Drug
Intervention Name(s)
Parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
Parsaclisib once daily for 8 weeks followed by once weekly
Primary Outcome Measure Information:
Title
Objective Response Rate Based on Lugano Classification Criteria in Group A
Description
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.
Time Frame
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Secondary Outcome Measure Information:
Title
Duration of Response in Group A
Description
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.
Time Frame
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Title
Progression-free Survival in Group A
Description
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.
Time Frame
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Title
Overall Survival (OS) in Group A
Description
Defined as the time from the date of the first dose of study drug until death by any cause.
Time Frame
From first dose of study drug until death by any cause; up to 26 months
Title
Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
Description
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.
Time Frame
Screening through 35 days after end of treatment, up to 42 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Corrado, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Sutter Gould Medical Foundation
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Asclepes Research Centers
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Facility Name
Advocate Medical Group Niles Milwaukee Ave
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Indiana BMT
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Kentucky Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0298
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
CHI Health - St. Francis Medical Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68802
Country
United States
Facility Name
Summit Medical Group
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901-1914
Country
United States
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Utah Cancer Specialists- Network
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Ballarat Base Hospital
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Cliniques Universitaires Ucl Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
LHSC - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Centre Antoine Lacassagne
City
Nice cedex 02
State/Province
Alpes Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Francois Baclesse
City
Caen Cedex 05
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
CHU Dijon - Hopital du Bocage
City
Dijon cedex
State/Province
Cote dÝOr
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Libourne
City
Libourne Cedex
State/Province
Gironde
ZIP/Postal Code
33505
Country
France
Facility Name
CHU de Grenoble - Hôpital Albert Michallon
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier d'Angers
City
Angers Cedex 01
State/Province
Maine Et Loire
ZIP/Postal Code
49033
Country
France
Facility Name
Hopital Claude Huriez - CHU Lille
City
Lille cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris cedex 10
State/Province
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans Cedex 02
State/Province
Sarthe
ZIP/Postal Code
72015
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil Cedex
State/Province
Val De Marne
ZIP/Postal Code
94010
Country
France
Facility Name
Chu de Grenoble - Hopital Albert Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Chu Vandoeuvre-Les-Nancy Hopital Brabois
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Malopolskie Centrum Medyczne s.c.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
ICO l´Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet de llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Clinica Universidad de Navarra (Cun)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
ZIP/Postal Code
01009
Country
Spain
Facility Name
The Christie
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Southend University Hospital
City
Southend-on-sea
ZIP/Postal Code
SS0 ORY
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33140664
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.
Results Reference
derived
Learn more about this trial
A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
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