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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

Useful links and downloads for this trial

Clinicaltrials.gov

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