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Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Sponsor: Princess Maxima Center for Pediatric Oncology
Summary
This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
Official title: Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
Key Details
Gender
All
Age Range
1 Day - 1 Year
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2022-12-15
Completion Date
2030-09
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
Blinatumomab
1st cycle: 15 μg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 μg/m2/day in week 1 followed by 15 μg/m2/day in weeks 2, 3, and 4.
Blinatumomab
2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
Locations (112)
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"
Buenos Aires, Argentina
Australian and New Zealand Children's Haematology/Oncology Group
Clayton, Victoria, Australia
North Adelaide- Womens and Childrens Hospital
Adelaide, Australia
Monash Children's Hosptial
Clayton, Australia
New Lambton Heights- John Hunter Children's Hospital
New Lambton Heights, Australia
Royal Children's Hospital (Children's Cancer Centre)
Parkville, Australia
Perth Children's Hospital
Perth, Australia
Queensland Children's Hospital
South Brisbane, Australia
Sydney Childrens Hospital
Sydney, Australia
The Childrens Hospital at Westmead
Westmead, Australia
Medical University Of Graz
Graz, Austria
Medical University Of Innsbruck
Innsbruck, Austria
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Salzburg, Austria
St. Anna Children's Hospital
Vienna, Austria
Antwerp University Hospital
Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Regional De La Citadelle
Liège, Belgium
CHC MontLegia
Liège, Belgium
University Hospital Brno
Brno, Czechia
University Hospital Olomouc
Olomouc, Czechia
Hospital Motol V Uvalu 841
Prague, Czechia
AUH Skejby
Aarhus, Denmark
Copenhagen-Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
New Children's Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
CHU Besancon
Besançon, France
CHU de Bordeaux
Bordeaux, France
HCE
Grenoble, France
CHRU de Lille
Lille, France
Institute of Hematology and Pediatric Oncology
Lyon, France
CHU Timone
Marseille, France
CHI Montpellier
Montpellier, France
CHU Nancy
Nancy, France
CHU Nantes
Nantes, France
CHU de Nice
Nice, France
Hôpital Robert Debré, APHP
Paris, France
TRS
Paris, France
CHU Reims
Reims, France
CHU Rennes
Rennes, France
CHU Charles Nicolle
Rouen, France
CHRU Strasbourg Hautepierre
Strasbourg, France
Universitätsklinikum Augsburg
Augsburg, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Universitaetsklinikum Bonn AöR
Bonn, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitaetsklinikum Erlangen AöR
Erlangen, Germany
Justus-Liebig-Universitaet Giessen
Giessen, Germany
Universitaetsklinikum Halle (Saale) AöR
Halle, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Universtitätsklinikum Eppendorf
Hamburg, Germany
Universitätsklinikum Heidelberg AöR
Heidelberg, Germany
Universitaetsklinikum Schleswig-Holstein AöR
Kiel, Germany
HELIOS Klinikum Krefeld GmbH
Krefeld, Germany
Johannes Gutenberg University Mainz
Mainz, Germany
Universitaetsklinikum Muenster AöR
Münster, Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany
Aghia Sophia' Children's Hospital
Athens, Greece
HeSPHO
Athens, Greece
University General Hospital Of Heraklion
Heraklion, Greece
Mitera
Marousi, Greece
University Semmelweis
Budapest, Hungary
University of Pécs
Pécs, Hungary
National Children's Cancer Service
Dublin, Ireland
L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
Naples, Italy
IRCCS Ospedale Pediatrico Bambino Gesù
Roma, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Trieste, Italy
University Of Verona Medical School
Verona, Italy
Chiba University Hospital
Chiba, Japan
Ehime University Hospital
Ehime, Japan
Hiroshima University Hospital
Hiroshima, Japan
Hokkaido University Hospital
Hokkaido, Japan
Hyogo Prefectural Kobe Childrens Hospital
Hyōgo, Japan
Kagoshima University Hospital
Kagoshima, Japan
Kanagawa Childrens Medical Center
Kanagawa, Japan
Kyoto Prefectural University of Medicine
Kyoto, Japan
Kyoto University Hospital
Kyoto, Japan
Mie University Hospital
Mie, Japan
Nagoya University Graduate School of Medicine
Nagoya, Japan
Osaka City General Hospital
Osaka, Japan
Osaka University Graduate School of Medicine 2-2
Osaka, Japan
Saitama Prefectural Childrens Medical Center
Saitama, Japan
Shizuoka Childrens Hospital
Shizuoka, Japan
National Center for Child Health and Development
Tokyo, Japan
The University of Tokyo Hospital
Tokyo, Japan
Tokyo Metropolitan Childre's Medical Center
Tokyo, Japan
Tohoku University Hospital
Tōhoku, Japan
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Princess Máxima Center for pediatric oncology
Utrecht, Utrecht, Netherlands
Christchurch Children's Hospital
Christchurch, New Zealand
Haukeland University Hospital
Bergen, Norway
St. Olavs Hospital
Trondheim, Norway
Instituto Portugues de Oncologica Lisboa
Lisbon, Portugal
Jeddah-King Abdulaziz Medical City
Jeddah, Saudi Arabia
King Abdulaziz Medical City, King Abdullah International Medical Research Center
Riyadh, Saudi Arabia
National Institute of Children's Diseases
Bratislava, Slovakia
Vall D'hebron Institut De Recerca
Barcelona, Spain
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
University Hospital Virgen Del Rocio S.L.
Seville, Spain
Hospital Universitario Y Politecnico La Fe
Valencia, Spain
Childrens Cancer Center Queen Silvia Children´s Hospital, Sahlgrenska University Hospital
Gothenburg, Sweden
Linkoping University Hospital
Linköping, Sweden
Skane University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden
Umea University Hospital
Umeå, Sweden
Children's UH
Uppsala, Sweden