A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
NCT ID: NCT03144674
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2017-12-18
2024-05-29
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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Cohort 1- Closed to Further enrollment
Participants who have received prior ibrutinib.
Parsaclisib
Parsaclisib at the protocol-defined dose.
Cohort 2
Participants who have not received a prior BTK inhibitor.
Parsaclisib
Parsaclisib at the protocol-defined dose.
Interventions
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Parsaclisib
Parsaclisib at the protocol-defined dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
* Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
* Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
* Eastern Cooperative Oncology Group performance status 0 to 2.
Exclusion Criteria
* History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
* Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
* Active graft versus host disease.
* Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-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
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Oncology Associates
Tempe, Arizona, United States
Torrance Health Association
Redondo Beach, California, United States
Sansum Clinic
Santa Barbara, California, United States
Central Coast Medical Oncology
Santa Maria, California, United States
UCLA Healthcare Hematology-Oncology
Santa Monica, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Loyola University Medical Center
Whittier, California, United States
Valley View Hospital
Glenwood Springs, Colorado, United States
St. Mary'S Hospital Regional Cancer Center
Grand Junction, Colorado, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Advanced Pharma Cr
Miami, Florida, United States
Boca Raton Clinical Research Medical Inc.
Plantation, Florida, United States
Asclepes Research Centers
Weeki Wachee, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Rush University Medical Center - Consultants in Hematology
Chicago, Illinois, United States
Clinical Trials of Swla Llc
Lake Charles, Louisiana, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Saint Luke'S Hospital of Kansas City
Kansas City, Missouri, United States
COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN
Las Vegas, Nevada, United States
Clinical Research Alliance
New Hyde Park, New York, United States
Nyu Cancer Institute
New York, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
White Plains Hospital
White Plains, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Charleston Hematology Oncology Associates Pa
Charleston, South Carolina, United States
Renovatio Clinical
The Woodlands, Texas, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aou Maggiore Della Carita
Rosario, , Argentina
Icon Cancer Care
Auchenflower, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Calvary North Adelaide Hospital
North Adelaide, South Australia, Australia
Cliniques Universitaires Ucl Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, , Belgium
Aalborg University Hospital
Aalborg, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Avicenne Hospital
Bobigny, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Chu Limoges - Hospital Le Cluzeau
Limoges, , France
Hopital Saint-Louis
Paris, , France
H�Pital Universitaire Piti�-Salp�Tri�Re
Paris, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Institute Gustave Roussy (Igr)
Villejuif, , France
Universit�Tsklinikum Essen
Essen, , Germany
Universitatsmedizin Gottingen
Göttingen, , Germany
Universit�Tsklinikum Schleswig-Holstein
Kiel, , Germany
Klinikum Ludwigshafen
Ludwigshafen, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Universit�Tsklinikum Ulm
Ulm, , Germany
Rambam Medical Center
Haifa, , Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�
Bologna, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, , Italy
Fondazione Centro San Raffaele - Milano
Milan, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Azienda Ospedaliera San Gerardo Di Monza
Monza, , Italy
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
Palermo, , Italy
Presidio Ospedaliero Pescara
Pescara, , Italy
Ospedale Delle Croci - Ematologia Ravenna
Ravenna, , Italy
Sapienza University
Rome, , Italy
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Gdansk, , Poland
Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?
Gdansk, , Poland
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Klinika Transplantacji Komorel Krwiotworczych
Warsaw, , Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Hospital General Universitari Vall D Hebron
Barcelona, , Spain
Ico Institut Catala D Oncologia
Barcelona, , Spain
Hgu Gregorio Maranon
Madrid, , Spain
Hospital Universitario Hm Sanchinarro
Madrid, , Spain
Hospital Universitario Quironsalud Madrid
Madrid, , Spain
Hospital Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Kent Oncology Centre - Maidstone Hospital
Maidstone, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
University of Southampton
Southampton, , 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
2017-000970-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 50465-204 (CITADEL-204)
Identifier Type: -
Identifier Source: org_study_id
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