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.
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.
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There are 84 Locations for this study
Birmingham Alabama, 35294, United States
Tempe Arizona, 85284, United States
Redondo Beach California, 90277, United States
Santa Barbara California, 93105, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Santa Rosa California, 95403, United States
Whittier California, 90603, United States
Whittier California, 90603, United States
Glenwood Springs Colorado, 81601, United States
Grand Junction Colorado, 81501, United States
Miami Florida, 33136, United States
Miami Florida, 33147, United States
Plantation Florida, 33322, United States
Weeki Wachee Florida, 34607, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Lake Charles Louisiana, 70601, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Kansas City Missouri, 64111, United States
Las Vegas Nevada, 89169, United States
New Hyde Park New York, 11042, United States
New York New York, 10016, United States
Nyack New York, 10960, United States
White Plains New York, 10601, United States
Durham North Carolina, 27705, United States
Canton Ohio, 44718, United States
Gettysburg Pennsylvania, 17325, United States
Charleston South Carolina, 29414, United States
The Woodlands Texas, 77380, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Rosario , S2000, Argentina
Auchenflower Queensland, 04066, Australia
Adelaide South Australia, 05000, Australia
North Adelaide South Australia, 05006, Australia
Brussels , 01200, Belgium
Gent , 9000, Belgium
Leuven , 03000, Belgium
Aalborg , 09000, Denmark
Roskilde , 04000, Denmark
Bobigny , 93000, France
Creteil , 94010, France
Limoges Cedex , 87042, France
Paris , 75010, France
Paris , 75013, France
Pierre-benite , 69495, France
Rouen , 76038, France
Villejuif , 94800, France
Essen , 45147, Germany
Gottingen , 37075, Germany
Kiel , 24105, Germany
Ludwigshafen , 67063, Germany
Mainz , 55131, Germany
ULM , 89081, Germany
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petach Tikva , 48414, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Bologna , 40138, Italy
Meldola , 47014, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Monza , 20900, Italy
Palermo , 90146, Italy
Pescara , 65124, Italy
Ravenna , 48121, Italy
Rome , 00161, Italy
Gdansk , 02-78, Poland
Gdansk , 80-95, Poland
Krakow , 30-51, Poland
Warsaw , 02-77, Poland
Warszawa , 02-78, Poland
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Madrid , 28007, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
Majadahonda , 28222, Spain
Salamanca , 37007, Spain
Birmingham , B9 5S, United Kingdom
Maidstone , ME16 , United Kingdom
Norwich , NR4 7, United Kingdom
Southampton , SO16 , United Kingdom
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