Spots Global Cancer Trial Database for A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)
Official Title: A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
Study ID: NCT04809467
Study Description
Brief Summary: The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama At Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
University of Southern California, Los Angeles, California, United States
Indiana Blood and Marrow Transplantation, Indianapolis, Indiana, United States
Community Health Network, Inc., Indianapolis, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Cancer Center For Blood Disorders, Bethesda, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Clinical Research Alliance, New Hyde Park, New York, United States
Ohio State University, Columbus, Ohio, United States
Jefferson University Hospitals, Philadelphia, Pennsylvania, United States
Ordensklinikum Linz Gmbh Elisabethinen, Linz, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse, Vienna, , Austria
Institut Jules Bordet, Brussels, , Belgium
Grand Hospital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen (Uza), Edegem, , Belgium
Az Groeninge Campus Kennedylaan, Kortrijk, , Belgium
Universitair Ziekenhuis (Uz) Leuven, Leuven, , Belgium
AZ DELTA, Roeselare, , Belgium
University Hospital Brest, Brest, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu, Nantes, , France
Centre Henri Becquerel, Rouen, , France
Institut Gustave Roussy, Villejuif, , France
University Medical Center Freiburg, Freiburg, , Germany
Justus-Liebig University, Giessen, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz, , Germany
University Hospital Wurzburg, Wurzburg, , Germany
S Orsolas University Hospital Seragnoli Institute of Hematology, Bologna, , Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori, Meldola, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori, Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale, Naples, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Ospedale Santa Maria Delle Croci, Ravenna, , Italy
Irccs Istituto Clinico Humanitas, Rozzano, , Italy
Hospital General Unviersitario de Alicante, Alicante, , Spain
Hospital General Universitario Vall D Hebron, Barcelona, , Spain
Hopital Sant Pau, Barcelona, , Spain
Ico Institut Catala D Oncologia, Barcelona, , Spain
Hospital Universitario San Cecilio, Granada, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Centro Integral Oncologico Clara Campal (Ciocc), Madrid, , Spain
Hospital Universitario Quironsalud Madrid, Madrid, , Spain
Hospital Puerta de Hierro, Majadahonda, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Oliver Manzke, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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