Non Hodgkin Lymphoma Clinical Trial
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
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).
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There are 83 Locations for this study
Phoenix Arizona, 85016, United States
Beverly Hills California, 90211, United States
Los Angeles California, 90036, United States
Santa Rosa California, 95403, United States
Whittier California, 90603, United States
Southington Connecticut, 06489, United States
Fort Myers Florida, 33901, United States
Spring Hill Florida, 34606, United States
Lake Charles Louisiana, 70601, United States
Baltimore Maryland, 21229, United States
Detroit Michigan, 48201, United States
Hattiesburg Mississippi, 39401, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64132, United States
New Hyde Park New York, 11042, United States
Durham North Carolina, 27710, United States
Canton Ohio, 44718, United States
Philadelphia Pennsylvania, 19104, United States
Charleston South Carolina, 29414, United States
Nashville Tennessee, 37203, United States
Spring Texas, 77380, United States
Seattle Washington, 98109, United States
St Albans Victoria, 03021, Australia
Wodonga Victoria, 03690, Australia
Darlinghurst , 02010, Australia
St. John New Brunswick, E2L 4, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H1T 1, Canada
Hradec Kralove , 500 0, Czechia
Ostrava , 708 5, Czechia
Prague , 10034, Czechia
Praha 5 , 15000, Czechia
Praha , 120 0, Czechia
Aalborg , 09000, Denmark
Odense C , 05000, Denmark
Dresden , 01307, Germany
Freiburg , 79106, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
Budapest , 01085, Hungary
Budapest , 01122, Hungary
Debrecen , 04032, Hungary
Kaposvar , 07400, Hungary
Hadera , 38100, Israel
Haifa , 31096, Israel
Netanya , 42150, Israel
Ramat Gan , 52621, Israel
Tel Aviv-yafo , 64239, Israel
Aviano , 33081, Italy
Bari , 70124, Italy
Bologna , 40126, Italy
Meldola , 47014, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Rome , 00161, Italy
San Giovanni Rotondo , 71013, Italy
Torino , 10126, Italy
Vicenza , 36100, Italy
Gdansk , 80-95, Poland
Krakow , 30-51, Poland
Opole , 45-37, Poland
Warszawa , 02-77, Poland
Warszawa , 02-78, Poland
Barcelona , 08026, Spain
Barcelona , 08035, Spain
Madrid , 28009, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
San Cristobal de La Laguna , 38320, Spain
Sevilla , 41007, Spain
Sevilla , 41013, Spain
Stockholm , 14141, Sweden
Birmingham , B9 5S, United Kingdom
London , SE5 9, United Kingdom
Sheffield , S10 2, United Kingdom
Sutton , SM2 5, United Kingdom
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