Detail of the clinical trial

Title of the trial Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in PediatricPatients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia In First or Second Relapse
EudraCT number 2018-002697-45
Protocol number ACT15378
Sponsor Sanofi-aventis recherche & développement, 1 avenue Pierre Brossolette, 913 80 Chilly-Mazarin, France
Indications Hemato-oncology
Diagnosis Lymphoblastic Leukemia or Myeloid Leukemia
Population in clinical trial Infants and Toddlers (28 days - 23 months)
Children (2-11 years)
Adolescents (12-17 years)
Year of receiving the request to Institute (SÚKL) 2020
Date of approval by Institute (SÚKL) 15.6.2020
Date of approval by EC
Date of initiation CT in ČR
Date of ending CT in ČR
Sites Fakultní nemocnice Brno,Klinika dětské onkologie - Dětská nemocnice,Čenopolní 9,Brno ,625 00
Fakultní nemocnice v Motole,Klinika dětské hematologie a onkologie 2.LF UK a FN Motol,V Úvalu 84,Praha 5,150 06

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