Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

December 15, 2022

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2030

Conditions
Acute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemia
Interventions
DRUG

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.

DRUG

Blinatumomab

2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion

Trial Locations (90)

Unknown

"Hospital de Pediatría S.A.M.I.C. Juan P. Garrahan", Buenos Aires

Australian and New Zealand Children's Haematology/Oncology Group, Clayton

North Adelaide- Womens and Childrens Hospital, Adelaide

Monash Children's Hosptial, Clayton

New Lambton Heights- John Hunter Children's Hospital, New Lambton Heights

Royal Children's Hospital (Children's Cancer Centre), Parkville

Perth Children's Hospital, Perth

Queensland Children's Hospital, South Brisbane

Sydney Childrens Hospital, Sydney

The Childrens Hospital at Westmead, Westmead

St. Anna Children's Hospital, Vienna

Antwerp University Hospital, Antwerp

Cliniques Universitaires Saint-Luc, Brussels

Hôpital Universitaire des Enfants Reine Fabiola, Brussels

Universitair Ziekenhuis Gent, Ghent

UZ Leuven, Leuven

Centre Hospitalier Regional De La Citadelle, Liège

CHC MontLegia, Liège

University Hospital Brno, Brno

University Hospital Olomouc, Olomouc

Hospital Motol V Uvalu 841, Prague

AUH Skejby, Aarhus

Copenhagen-Rigshospitalet, Copenhagen

Odense University Hospital, Odense

New Children's Hospital, Helsinki

Kuopio University Hospital, Kuopio

Oulu University Hospital, Oulu

Tampere University Hospital, Tampere

CHU Besancon, Besançon

Institute of Hematology and Pediatric Oncology, Lyon

Hôpital Robert Debré, APHP, Paris

CHU Charles Nicolle, Rouen

Universitätsklinikum Augsburg, Augsburg

Charite Universitaetsmedizin Berlin KöR, Berlin

Klinikum Dortmund gGmbH, Dortmund

Justus-Liebig-Universitaet Giessen, Giessen

Universitaetsklinikum Halle (Saale) AöR, Halle

University Medical Center Hamburg-Eppendorf, Hamburg

Universtitätsklinikum Eppendorf, Hamburg

Universitätsklinikum Heidelberg AöR, Heidelberg

Universitaetsklinikum Schleswig-Holstein AöR, Kiel

HELIOS Klinikum Krefeld GmbH, Krefeld

Universitaetsklinikum Muenster AöR, Münster

Klinikum Der Landeshauptstadt Stuttgart gKAöR, Stuttgart

Universitaetsklinikum Tuebingen AöR, Tübingen

Aghia Sophia' Children's Hospital, Athens

HeSPHO, Athens

University General Hospital Of Heraklion, Heraklion

Mitera, Marousi

University Semmelweis, Budapest

University of Pécs, Pécs

National Children's Cancer Service, Dublin

L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon, Napoli

IRCCS Ospedale Pediatrico Bambino Gesù, Roma

Chiba University Hospital, Chiba

Ehime University Hospital, Ehime

Hiroshima University Hospital, Hiroshima

Hokkaido University Hospital, Hokkaido

Hyogo Prefectural Kobe Childrens Hospital, Hyōgo

Kagoshima University Hospital, Kagoshima

Kanagawa Childrens Medical Center, Kanagawa

Kyoto Prefectural University of Medicine, Kyoto

Kyoto University Hospital, Kyoto

Mie University Hospital, Mie

Nagoya University Graduate School of Medicine, Nagoya

Osaka City General Hospital, Osaka

Osaka University Graduate School of Medicine 2-2, Osaka

Saitama Prefectural Childrens Medical Center, Saitama

Shizuoka Childrens Hospital, Shizuoka

National Center for Child Health and Development, Tokyo

The University of Tokyo Hospital, Tokyo

Tokyo Metropolitan Childre's Medical Center, Tokyo

Tohoku University Hospital, Tōhoku

Vilnius University Hospital Santaros Klinikos, Vilnius

Haukeland University Hospital, Bergen

St. Olavs Hospital, Trondheim

Instituto Portugues de Oncologica Lisboa, Lisbon

Jeddah-King Abdulaziz Medical City, Jeddah

King Abdulaziz Medical City, King Abdullah International Medical Research Center, Riyadh

National Institute of Children's Diseases, Bratislava

Vall D'hebron Institut De Recerca, Barcelona

Hospital Infantil Universitario Nino Jesus, Madrid

University Hospital Virgen Del Rocio S.L., Seville

Hospital Universitario Y Politecnico La Fe, Valencia

Childrens Cancer Center Queen Silvia Children´s Hospital, Sahlgrenska University Hospital, Gothenburg

Linkoping University Hospital, Linköping

Skane University Hospital, Lund

Karolinska University Hospital, Stockholm

Umea University Hospital, Umeå

3584 CS

Princess Máxima Center for pediatric oncology, Utrecht

All Listed Sponsors
collaborator

University of Milano Bicocca

OTHER

collaborator

Amgen Europe B.V

UNKNOWN

lead

Princess Maxima Center for Pediatric Oncology

OTHER