Non Hodgkin Lymphoma Clinical Trial
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton’s Tyrosine Kinase (BTK) Inhibitor
Summary
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Eligibility Criteria
Inclusion Criteria:
Men and women, aged 18 years or older.
Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 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.
Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.
Active graft-versus-host disease.
Liver 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 101 Locations for this study
Birmingham Alabama, 35205, United States
Santa Rosa California, 95403, United States
Aurora Colorado, 80012, United States
Brooksville Florida, 34613, United States
Tampa Florida, 33647, United States
Winter Haven Florida, 33880, United States
Chicago Illinois, 60612, United States
Maywood Illinois, 60153, United States
Niles Illinois, 60714, United States
Hattiesburg Mississippi, 39401, United States
New Hyde Park New York, 11042, United States
Durham North Carolina, 27705, United States
Cincinnati Ohio, 45230, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97227, United States
Gettysburg Pennsylvania, 17325, United States
Austin Texas, 78705, United States
San Antonio Texas, 78240, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Yakima Washington, 98902, United States
Gent Oost-Vlaanderen, 9000, Belgium
Brussels , , Belgium
La Louviere , 07100, Belgium
Leuven , 03000, Belgium
Hradec Kralove , 500 0, Czechia
Prague 10 , 500 0, Czechia
Prague 2 , 128 0, Czechia
Prague , 10034, Czechia
Aalborg , 09000, Denmark
Aarhus , DK-80, Denmark
Odense C , 05000, Denmark
Roskilde , 04000, Denmark
Bobigny , 93000, France
Clermont-ferrand , 63230, France
Creteil , 94010, France
Grenoble , 38043, France
La Roche Sur Yon , 85925, France
La Tronche , 38700, France
Le Chesnay , 78157, France
Lyon , 69008, France
Nice , 06189, France
Paris , 75010, France
Paris , 75013, France
Pierre-Bénite Cedex , 69310, France
Poitiers , 86021, France
Rouen , 76038, France
Tours , 37044, France
Villejuif Cedex , 94805, France
Augsburg , 86150, Germany
Essen , 45122, Germany
Essen , 45147, Germany
Giessen , 35392, Germany
Mainz , 55131, Germany
Moenchengladbach , 41063, Germany
Munchen , 80634, Germany
ULM , 89081, Germany
Haifa , 31096, Israel
Jerusalem , 90000, Israel
Jerusalem , 91120, Israel
Petach Tikva , 48414, Israel
Tel Aviv , 64239, Israel
Milano MI, 20133, Italy
Bologna , 40138, Italy
Catania , 95123, Italy
Milano , 20162, Italy
Milano , 22162, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Rome , 00161, Italy
Siena , 53100, Italy
Torino , 10126, Italy
Bielsko-biala , 43-30, Poland
Brzozow , 36-20, Poland
Gdansk , 80-95, Poland
Krakow , 30-51, Poland
Tomaszow Mazowiecki , 97-20, Poland
Warszawa , 02-78, Poland
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08221, Spain
Barcelona , 08916, Spain
Burgos , 09006, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Murcia , 30008, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Sevilla , 41005, Spain
Valencia , 46015, Spain
Valencia , 46017, Spain
Valencia , 46026, Spain
Birmingham , B9 5S, United Kingdom
Edinburgh , EH4 2, United Kingdom
London , NW1 2, United Kingdom
Plymouth , PL6 8, United Kingdom
Sheffield , S10 2, United Kingdom
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