Clinical trial NCT03126019: A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
Official title: A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Follicular lymphoma
non-Hodgkin lymphoma (NHL)
phosphatidylinositol 3-kinase (PI3K) δ inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older.
* Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.
* Ineligible for hematopoietic stem cell transplant.
* Must have been treated with at least 2 prior systemic therapies.
* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
* Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

* Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
* History of central nervous system lymphoma (either primary or metastatic).
* Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan-PI3K inhibitor.
* Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
* Active graft-versus-host disease.
* Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).

Primary outcomes:
measure: Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
timeFrame: Up to approximately 148 weeks
Secondary outcomes:
measure: Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
timeFrame: Up to 1193 days
measure: Duration of Response (DOR)
timeFrame: Up to 1193 days
measure: Progression-free Survival (PFS) With Parsaclisib
timeFrame: Up to 1193 days
measure: Overall Survival (OS) With Parsaclisib
timeFrame: Up to 1193 days
measure: Best Percent Change From Baseline in Target Lesion Size
timeFrame: Up to 1193 days
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: up to approximately 1992 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates - Biltmore Cancer Center
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Los Angeles
country: United States
facility: Synergy Hematology and Oncology Medical Associates
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Whittier
country: United States
facility: American Institute of Research Corporate Office
state: California
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Centers
state: Florida
city: Lake Charles
country: United States
facility: Clinical Trials of Swla Llc
state: Louisiana
city: Baltimore
country: United States
facility: Saint Agnes Hospital
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Hospital
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke'S Hospital
state: Missouri
city: Kansas City
country: United States
facility: Sarah Cannon Research Institute
state: Missouri
city: New Hyde Park
country: United States
facility: Clinical Research Alliance, Inc.
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates Pa
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Spring
country: United States
facility: Renovatio Clinical Consultants Llc
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: St Albans
country: Australia
facility: Western Health
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Darlinghurst
country: Australia
facility: St Vincent'S Hospital Sydney
city: St. John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Montreal
country: Canada
facility: Santa Cabrini Hospital
state: Quebec
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Prague
country: Czechia
facility: University Hospital Kralovkse Vinohrady
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice V Motole
city: Praha
country: Czechia
facility: Univerzita Karlova V Praze 1. Lekarska Fakulta
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital (Ouh) (Odense University Hospital)
city: Dresden
country: Germany
facility: Bag Arnoldstr. Dresden
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Kaposvar
country: Hungary
facility: Somogy Medyei Kaposi Mor Oktato Korhaz
city: Hadera
country: Israel
facility: Hillel Yafe Medical Center (Hymc)
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Netanya
country: Israel
facility: Laniado Hospital Hematology
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv-yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
city: Bologna
country: Italy
facility: University of Bologna
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Modena
country: Italy
facility: A.O.U. Di Modena - Policlinico
city: Napoli
country: Italy
facility: A.O.U. Federico Ii
city: Novara
country: Italy
facility: Aou Maggiore Della Carita
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia Cervello
city: Rome
country: Italy
facility: Sapienza University
city: San Giovanni Rotondo
country: Italy
facility: I.R.C.C.S. Casa Sollievo Della Sofferenza
city: Torino
country: Italy
facility: Aou Citta Della Salute E Della Scienza Di Torino
city: Vicenza
country: Italy
facility: San Bartolo Hospital
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Pratia McM Krakow
city: Opole
country: Poland
facility: State Hospital Opole
city: Warszawa
country: Poland
facility: Institute of Hematology and Transfusion Medicine
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D Hebron
city: Madrid
country: Spain
facility: Hgu Gregorio Maranon
city: Madrid
country: Spain
facility: Md Anderson Cancer Centre Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Hm Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: San Cristobal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Huddinge
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Nhs Foundation Trust - Chelsea
Study officials:
affiliation: Incyte Corporation
name: Fred Zheng, MD, PhD
role: STUDY_DIRECTOR
References: