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.

View Eligibility Criteria

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).

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

161

Study ID:

NCT03235544

Recruitment Status:

Active, not recruiting

Sponsor:

Incyte Corporation

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There are 101 Locations for this study

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University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35205, United States
St. Joseph Heritage Healthcare
Santa Rosa California, 95403, United States
Rocky Mountain Cancer Center-Aurora
Aurora Colorado, 80012, United States
Asclepes Research Centers
Brooksville Florida, 34613, United States
Moffitt Cancer Center
Tampa Florida, 33647, United States
Bond & Steele Clinic, P.A.
Winter Haven Florida, 33880, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Hattiesburg Clinic Hematology
Hattiesburg Mississippi, 39401, United States
Clinical Research Alliance, Inc.
New Hyde Park New York, 11042, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Oncology Hematology Care, Inc.
Cincinnati Ohio, 45230, United States
Willamette Valley Cancer Institute
Eugene Oregon, 97401, United States
Kaiser Permanente - Northwest
Portland Oregon, 97227, United States
Gettysburg Cancer Center
Gettysburg Pennsylvania, 17325, United States
Texas Oncology
Austin Texas, 78705, United States
Texas Oncology San Antonio
San Antonio Texas, 78240, United States
Renovatio Clinical
The Woodlands Texas, 77380, United States
Texas Oncology - Tyler
Tyler Texas, 75702, United States
Yakima Valley Memorial Hospital/North Star
Yakima Washington, 98902, United States
Universitair Ziekenhuis Gent
Gent Oost-Vlaanderen, 9000, Belgium
Institut Jules Bordet
Brussels , , Belgium
Hopital de Jolimont
La Louviere , 07100, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven , 03000, Belgium
Fakultni Nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague 10 , 500 0, Czechia
Charles University General Hospital
Prague 2 , 128 0, Czechia
Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika
Prague , 10034, Czechia
Aalborg University Hospital
Aalborg , 09000, Denmark
Aarhus Universitets Hospital
Aarhus , DK-80, Denmark
Odense Universitetshospital (Ouh) (Odense University Hospital)
Odense C , 05000, Denmark
Zealand University Hospital
Roskilde , 04000, Denmark
Avicenne Hospital
Bobigny , 93000, France
Chu de Clermont - Ferrand- Hospital Estaing
Clermont-ferrand , 63230, France
Centre Hospitalier Universitaire Henri Mondor
Creteil , 94010, France
University Hospital Grenoble
Grenoble , 38043, France
Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies
La Roche Sur Yon , 85925, France
Centre Hospitalier Universitaire de Grenoble
La Tronche , 38700, France
Centre Hospitalier de Versailles
Le Chesnay , 78157, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Lyon , 69008, France
Centre Antoine Lacassagne
Nice , 06189, France
Hopital Saint-Louis
Paris , 75010, France
H�Pital Universitaire Piti�-Salp�Tri�Re
Paris , 75013, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite Cedex , 69310, France
Centre Hospitalier Universitaire de Poitiers
Poitiers , 86021, France
Centre Henri Becquerel
Rouen , 76038, France
Chru Hopitaux de Tours, Hospital Bretonneau
Tours , 37044, France
Institute Gustave Roussy (Igr)
Villejuif Cedex , 94805, France
Praxis Brudler, Heinrich, Bangerter
Augsburg , 86150, Germany
Universitaetsklinikum Essen
Essen , 45122, Germany
Universit�Tsklinikum Essen
Essen , 45147, Germany
Justus-Liebig University
Giessen , 35392, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz , 55131, Germany
Kliniken Maria Hilf
Moenchengladbach , 41063, Germany
Rotkreuzklinikum Munich
Munchen , 80634, Germany
Universit�Tsklinikum Ulm
ULM , 89081, Germany
Rambam Medical Center
Haifa , 31096, Israel
Hadassah Hebrew University Medical Center
Jerusalem , 90000, Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem , 91120, Israel
Rabin Medical Center - Beilinson Hospital
Petach Tikva , 48414, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano MI, 20133, Italy
Centro Ricerche Cliniche
Bologna , 40138, Italy
Azienda Policlinico Vittorio Emanuele
Catania , 95123, Italy
Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Ospedale Niguarda Ca Granda
Milano , 22162, Italy
A.O.U. Di Modena - Policlinico
Modena , 41124, Italy
A.O.U. Federico Ii
Napoli , 80131, Italy
Aou Maggiore Della Carita
Novara , 28100, Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo , 90146, Italy
Sapienza University
Rome , 00161, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena , 53100, Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino , 10126, Italy
Beskidzkie Centrum Onkologii Im.Jana Pawla Ii
Bielsko-biala , 43-30, Poland
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozow , 36-20, Poland
University Clinical Center
Gdansk , 80-95, Poland
Pratia McM Krakow
Krakow , 30-51, Poland
Nu-Med Centrum Diagnostykii I Terapii Onkologicznej
Tomaszow Mazowiecki , 97-20, Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Hospital Del Mar
Barcelona , 08003, Spain
Hospital General Universitari Vall D Hebron
Barcelona , 08035, Spain
Hospital Universitari Mutua Terrassa
Barcelona , 08221, Spain
Institut Catala D Oncologia
Barcelona , 08916, Spain
Hospital Universitario de Burgos
Burgos , 09006, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Md Anderson Cancer Centre Madrid
Madrid , 28033, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Fundacion Jimenez Diaz University Hospital
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario de La Paz
Madrid , 28046, Spain
Hospital General Universitario Morales Meseguer
Murcia , 30008, Spain
Complejo Hospitalario de Navarra
Pamplona , 31008, Spain
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41005, Spain
Hospital Arnau de Vilanova
Valencia , 46015, Spain
Hospital Universitario Dr. Peset
Valencia , 46017, Spain
Hospital Universitario Y Politecnic La Fe
Valencia , 46026, Spain
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Western General Hospital
Edinburgh , EH4 2, United Kingdom
University College London Hospitals (Uclh)
London , NW1 2, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Royal Hallamshire Hospital
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

161

Study ID:

NCT03235544

Recruitment Status:

Active, not recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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