Non Hodgkin Lymphoma Clinical Trial

A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Summary

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men and women, aged 18 or older (except in South Korea, aged 19 or older).
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:

Evidence of diffuse large B-cell transformation.
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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT03144674

Recruitment Status:

Active, not recruiting

Sponsor:

Incyte Corporation

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There are 84 Locations for this study

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University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Arizona Oncology Associates
Tempe Arizona, 85284, United States
Torrance Health Association
Redondo Beach California, 90277, United States
Sansum Clinic
Santa Barbara California, 93105, United States
Central Coast Medical Oncology
Santa Maria California, 93454, United States
UCLA Healthcare Hematology-Oncology
Santa Monica California, 90404, United States
St. Joseph Heritage Healthcare
Santa Rosa California, 95403, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
Loyola University Medical Center
Whittier California, 90603, United States
Valley View Hospital
Glenwood Springs Colorado, 81601, United States
St. Mary'S Hospital Regional Cancer Center
Grand Junction Colorado, 81501, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Advanced Pharma Cr
Miami Florida, 33147, United States
Boca Raton Clinical Research Medical Inc.
Plantation Florida, 33322, United States
Asclepes Research Centers
Weeki Wachee Florida, 34607, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago Illinois, 60611, United States
Rush University Medical Center - Consultants in Hematology
Chicago Illinois, 60612, United States
Clinical Trials of Swla Llc
Lake Charles Louisiana, 70601, United States
University of Michigan Cancer Center
Ann Arbor Michigan, 48109, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Saint Luke'S Hospital of Kansas City
Kansas City Missouri, 64111, United States
COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN
Las Vegas Nevada, 89169, United States
Clinical Research Alliance
New Hyde Park New York, 11042, United States
Nyu Cancer Institute
New York New York, 10016, United States
Hematology Oncology Associates of Rockland
Nyack New York, 10960, United States
White Plains Hospital
White Plains New York, 10601, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
Gettysburg Cancer Center
Gettysburg Pennsylvania, 17325, United States
Charleston Hematology Oncology Associates Pa
Charleston South Carolina, 29414, United States
Renovatio Clinical
The Woodlands Texas, 77380, United States
University of Washington - Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Aou Maggiore Della Carita
Rosario , S2000, Argentina
Icon Cancer Care
Auchenflower Queensland, 04066, Australia
Royal Adelaide Hospital
Adelaide South Australia, 05000, Australia
Calvary North Adelaide Hospital
North Adelaide South Australia, 05006, Australia
Cliniques Universitaires Ucl Saint-Luc
Brussels , 01200, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven , 03000, Belgium
Aalborg University Hospital
Aalborg , 09000, Denmark
Zealand University Hospital
Roskilde , 04000, Denmark
Avicenne Hospital
Bobigny , 93000, France
Centre Hospitalier Universitaire Henri Mondor
Creteil , 94010, France
Chu Limoges - Hospital Le Cluzeau
Limoges Cedex , 87042, France
Hopital Saint-Louis
Paris , 75010, France
H�Pital Universitaire Piti�-Salp�Tri�Re
Paris , 75013, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-benite , 69495, France
Centre Henri Becquerel
Rouen , 76038, France
Institute Gustave Roussy (Igr)
Villejuif , 94800, France
Universit�Tsklinikum Essen
Essen , 45147, Germany
Universitatsmedizin Gottingen
Gottingen , 37075, Germany
Universit�Tsklinikum Schleswig-Holstein
Kiel , 24105, Germany
Klinikum Ludwigshafen
Ludwigshafen , 67063, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz , 55131, Germany
Universit�Tsklinikum Ulm
ULM , 89081, Germany
Rambam Medical Center
Haifa , 31096, Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem , 91120, Israel
Rabin Medical Center - Beilinson Hospital
Petach Tikva , 48414, Israel
Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�
Bologna , 40138, Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola , 47014, Italy
Fondazione Centro San Raffaele - Milano
Milano , 20132, Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano , 20133, Italy
Azienda Ospedaliera San Gerardo Di Monza
Monza , 20900, Italy
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
Palermo , 90146, Italy
Presidio Ospedaliero Pescara
Pescara , 65124, Italy
Ospedale Delle Croci - Ematologia Ravenna
Ravenna , 48121, Italy
Sapienza University
Rome , 00161, Italy
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Gdansk , 02-78, Poland
Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?
Gdansk , 80-95, Poland
Malopolskie Centrum Medyczne S.C.
Krakow , 30-51, Poland
Klinika Transplantacji Komorel Krwiotworczych
Warsaw , 02-77, Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Hospital General Universitari Vall D Hebron
Barcelona , 08035, Spain
Ico Institut Catala D Oncologia
Barcelona , 08908, Spain
Hgu Gregorio Maranon
Madrid , 28007, Spain
Hospital Universitario Hm Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Quironsalud Madrid
Madrid , 28223, Spain
Hospital Puerta de Hierro
Majadahonda , 28222, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Kent Oncology Centre - Maidstone Hospital
Maidstone , ME16 , United Kingdom
Norfolk and Norwich University Hospital
Norwich , NR4 7, United Kingdom
University of Southampton
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT03144674

Recruitment Status:

Active, not recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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