A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
- Registration Number
- NCT02998476
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Parsaclisib (no prior BTK inhibitor) Parsaclisib Parsaclisib in subjects who were not previously treated with a BTK inhibitor. Group B Parsaclisib (prior BTK inhibitor) Parsaclisib Parsaclisib in subjects who were previously treated with a BTK inhibitor.
- Primary Outcome Measures
Name Time Method Objective Response Rate Based on Lugano Classification Criteria in Group A Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months 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
Name Time Method Progression-free Survival in Group A Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months 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 From first dose of study drug until death by any cause; up to 26 months Defined as the time from the date of the first dose of study drug until death by any cause.
Duration of Response in Group A Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months 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.
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 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.
Trial Locations
- Locations (70)
Asclepes Research Centers
🇺🇸Weeki Wachee, Florida, United States
Arizona Oncology Associates, PC - HAL
🇺🇸Tempe, Arizona, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Cliniques Universitaires Ucl Saint-Luc
🇧🇪Brussels, Belgium
LHSC - Victoria Hospital
🇨🇦London, Ontario, Canada
Centre Hospitalier Libourne
🇫🇷Libourne Cedex, Gironde, France
Hôpital Henri Mondor
🇫🇷Créteil Cedex, Val De Marne, France
CHI Health - St. Francis Medical Center
🇺🇸Grand Island, Nebraska, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Ballarat Base Hospital
🇦🇺Ballarat, Victoria, Australia
Clinical Research Alliance
🇺🇸Lake Success, New York, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
ZNA Stuivenberg
🇧🇪Antwerpen, Belgium
St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Advocate Medical Group Niles Milwaukee Ave
🇺🇸Niles, Illinois, United States
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
AZ Delta
🇧🇪Roeselare, Belgium
Utah Cancer Specialists- Network
🇺🇸Salt Lake City, Utah, United States
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
UZ Leuven
🇧🇪Leuven, Belgium
Summit Medical Group
🇺🇸Morristown, New Jersey, United States
CHU de Grenoble - Hôpital Albert Michallon
🇫🇷Grenoble, Isere, France
Hopital Claude Huriez - CHU Lille
🇫🇷Lille cedex, Nord, France
Sutter Gould Medical Foundation
🇺🇸Modesto, California, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
University of Kentucky Hospital
🇺🇸Lexington, Kentucky, United States
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Indiana BMT
🇺🇸Beech Grove, Indiana, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
University Hospital Ostrava
🇨🇿Ostrava, Czechia
Centre Francois Baclesse
🇫🇷Caen Cedex 05, Calvados, France
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Centre Antoine Lacassagne
🇫🇷Nice cedex 02, Alpes Maritimes, France
CHU Dijon - Hopital du Bocage
🇫🇷Dijon cedex, Cote dÝOr, France
Centre Hospitalier d'Angers
🇫🇷Angers Cedex 01, Maine Et Loire, France
Clinique Victor Hugo - Centre Jean Bernard
🇫🇷Le Mans Cedex 02, Sarthe, France
Hôpital Saint-Louis
🇫🇷Paris cedex 10, Paris, France
Chu de Grenoble - Hopital Albert Michallon
🇫🇷Grenoble, France
Chu Vandoeuvre-Les-Nancy Hopital Brabois
🇫🇷Vandoeuvre-les-nancy, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Groupe Hospitalier Pitie-Salpetriere
🇫🇷Paris, France
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
🇮🇹Bari, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
🇮🇹Rome, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
🇮🇹Meldola, Italy
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
🇵🇱Brzozów, Poland
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Hospital del Mar
🇪🇸Barcelona, Spain
ICO l´Hospitalet - Hospital Duran i Reynals
🇪🇸L'Hospitalet de llobregat, Barcelona, Spain
Malopolskie Centrum Medyczne s.c.
🇵🇱Krakow, Poland
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Clinica Universidad de Navarra (Cun)
🇪🇸Pamplona, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Spain
The Christie
🇬🇧Manchester, Greater Manchester, United Kingdom
Southend University Hospital
🇬🇧Southend-on-sea, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States