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Brief Title: Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
Official Title: A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Study ID: NCT04524455
Brief Summary: The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
University of Chicago, Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Royal Adelaide Hospital, Adelaide, South Australia, Australia
The Royal Melbourne Hospital, Parkville, Victoria, Australia
Ordensklinikum Linz Elisabethinen, Linz, , Austria
Hôpital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main, , Germany
Universitätsklinikum Schleswig-Holstein, Kiel, , Germany
Universitaetsklinikum Regensburg, Regensburg, , Germany
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi, Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, , Italy
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Hospital Universitari Germans Trias i Pujol, Badalona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain
University College London, London, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR