A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
NCT ID: NCT03126019
Last Updated: 2025-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2018-03-14
2024-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW
Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.
Parsaclisib
Parsaclisib tablets administered orally with water and without regard to food
Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Parsaclisib
Parsaclisib tablets administered orally with water and without regard to food
Interventions
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Parsaclisib
Parsaclisib tablets administered orally with water and without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Zheng, MD, PhD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Arizona Oncology Associates - Biltmore Cancer Center
Phoenix, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Synergy Hematology and Oncology Medical Associates
Los Angeles, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
American Institute of Research Corporate Office
Whittier, California, United States
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Asclepes Research Centers
Spring Hill, Florida, United States
Clinical Trials of Swla Llc
Lake Charles, Louisiana, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, United States
Hattiesburg Clinic Hematology
Hattiesburg, Mississippi, United States
Saint Luke'S Hospital
Kansas City, Missouri, United States
Sarah Cannon Research Institute
Kansas City, Missouri, United States
Clinical Research Alliance, Inc.
New Hyde Park, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Charleston Hematology Oncology Associates Pa
Charleston, South Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Renovatio Clinical Consultants Llc
Spring, Texas, United States
University of Washington
Seattle, Washington, United States
Western Health
St Albans, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
St Vincent'S Hospital Sydney
Darlinghurst, , Australia
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Santa Cabrini Hospital
Montreal, Quebec, Canada
University Hospital Hradec Kralove
Hradec Králové, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
University Hospital Kralovkse Vinohrady
Prague, , Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta
Prague, , Czechia
Fakultni Nemocnice V Motole
Prague, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Odense Universitetshospital (Ouh) (Odense University Hospital)
Odense C, , Denmark
Bag Arnoldstr. Dresden
Dresden, , Germany
University Medical Center Freiburg
Freiburg im Breisgau, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
University Hospital Mannheim
Mannheim, , Germany
Semmelweis Egyetem
Budapest, , Hungary
National Institute of Oncology
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Somogy Medyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Hillel Yafe Medical Center (Hymc)
Hadera, , Israel
Rambam Medical Center
Haifa, , Israel
Laniado Hospital Hematology
Netanya, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Irccs Centro Di Riferimento Oncologico
Aviano, , Italy
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, , Italy
University of Bologna
Bologna, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
A.O.U. Di Modena - Policlinico
Modena, , Italy
A.O.U. Federico Ii
Napoli, , Italy
Aou Maggiore Della Carita
Novara, , Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo, , Italy
Sapienza University
Rome, , Italy
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, , Italy
Aou Citta Della Salute E Della Scienza Di Torino
Torino, , Italy
San Bartolo Hospital
Vicenza, , Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Pratia McM Krakow
Krakow, , Poland
State Hospital Opole
Opole, , Poland
Institute of Hematology and Transfusion Medicine
Warsaw, , Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital General Universitari Vall D Hebron
Barcelona, , Spain
Hgu Gregorio Maranon
Madrid, , Spain
Md Anderson Cancer Centre Madrid
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario de La Paz
Madrid, , Spain
Hospital Universitario Hm Sanchinarro
Madrid, , Spain
Hospital Universitario Quironsalud Madrid
Madrid, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Karolinska University Hospital, Huddinge
Stockholm, , Sweden
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Northwick Park Hospital
London, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
Sutton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Parsaclisib
Identifier Type: OTHER
Identifier Source: secondary_id
2017-001624-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 50465-203 (CITADEL-203)
Identifier Type: -
Identifier Source: org_study_id
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