Detail of the clinical trial

Title of the trial A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network.
EudraCT number 2016-004674-17
Protocol number NL59901.078.17
Sponsor Princess Máxima Center for Pediatric Oncology, Uppsalalaan 8, 3584 CT Utrecht, The Netherlands
Indications Hemato-oncology
Diagnosis lymphoblastic leukemia
Population in clinical trial Infants and Toddlers (28 days - 23 months)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2018
Date of approval by Institute (SÚKL) 3.12.2018
Date of approval by EC
Date of initiation CT in ČR 9.4.2020
Date of ending CT in ČR
Notice
Sites Princess Margaret Hospital for Children,,,Perth,
Charite,,,Berlin,
University Children?s Hospital Essen,,,Essen,
Klinikum der Universität München Dr. Von Haunersches Kinderspital ,,,,
Pediatric Hematology Oncology - Azienda Ospedaliera PD,,,Padova,
NA Pausilipon,,,Napoli,
Ospedale Pediatrico Bambino Gesu IRCCS,,,Rome,
HME, CHU Nantes,,,Nantes,
Timone Enfants,,,Marseille,
The Children's Hospital at Westmead,,,Sydney,
Royal Children's Hospital,,,Melbourne,
Lady Cilento Children's Hospital,,,Brisbane,
University Hospital Motol,,,Praque,
Klinikum der Universität München Dr. Von Haunersches Kinderspital,,,Munchen,
University hospital Hamburg Eppendorf,,,Hamburg,
Great Ormond Street Hospital,,,London,
St. Anna Children's Hospital,,,Vienna,
Robert Debre Hospital - APHP,,,Paris,
University Hospital Rigshospitalet,,,Copenhagen,
Hôpital Universitaire des Enfants Reine Fabiola,,,Brussels,
Clinica Pediatrica Ospedale San Gerardo ASST,,,Monza,
Princess Máxima Center for Pediatric Oncology,,Uppsalalaan 8,Utrecht,3584 CT

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