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NCT05327894RecruitingPhase 3

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

Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
160 (estimated)
First submitted
7 Apr 2022
Start date
15 Dec 2022
Primary completion date
Sept 2027
Lead sponsor
Princess Maxima Center for Pediatric Oncology
NCT number
NCT05327894
EU CT number
2022-502503-30-00
EudraCT number
2021-000213-16

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 160
  • From 15 Dec 2022 to the primary completion date, Sept 2027
  • 168 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with systemic corticosteroids (equivalent prednisone \>10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
    • If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.

Other illness

  • Down syndrome.

Age

  • Age \> 365 days at the time of diagnosis.

Other

  • KMT2A-wildtype patients.
  • Multilineage MPAL
  • T-ALL.
  • Relapsed ALL.

Who the study is looking for

  • Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement.
  • ≤ 365 days of age at the time of diagnosis of ALL.
  • Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.

Age in the registry: 1 day to 1 year · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (168)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"
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Buenos AiresArgentinaSuspended
Medical University of Graz
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GrazAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
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SalzburgAustriaActive, not recruiting
St. Anna Kinderspital GmbH
Coordinator of this site? Confirm its status
ViennaAustriaActive, not recruiting
St. Anna Childrens Cancer Research Institute GmbH
Coordinator of this site? Confirm its status
ViennaAustriaActive, not recruiting
North Adelaide- Womens and Childrens Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Monash Children's Hosptial
Coordinator of this site? Confirm its status
ClaytonAustraliaActive, not recruiting
Australian and New Zealand Children's Haematology/Oncology Group
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
New Lambton Heights- John Hunter Children's Hospital
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New Lambton HeightsAustraliaRecruiting
Royal Children's Hospital (Children's Cancer Centre)
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ParkvilleAustraliaActive, not recruiting
Perth Children's Hospital
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PerthAustraliaRecruiting
Queensland Children's Hospital
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South BrisbaneAustraliaActive, not recruiting
Sydney Childrens Hospital
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SydneyAustraliaRecruiting
The Childrens Hospital At Westmead
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WestmeadAustraliaRecruiting
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
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BrusselsBelgiumRecruiting
Antwerp University Hospital
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Fakultni Nemocnice Brno
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Brno-SeverCzechiaRecruiting
University Hospital Olomouc
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OlomoucCzechiaRecruiting
Fakultni Nemocnice V Motole
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Prague 5CzechiaRecruiting
Universitaetsklinikum Aachen AöR
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AachenGermanyRecruiting
Universitaetsklinikum Augsburg
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AugsburgGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Gesundheit Nord gGmbH Klinikverbund Bremen
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BremenGermanyRecruiting
University Hospital Cologne AöR
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CologneGermanyRecruiting
Klinikum Dortmund gGmbH
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DortmundGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Justus-Liebig-Universitaet Giessen
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GiessenGermanyRecruiting
Universitaetsklinikum Halle (Saale) AöR
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Halle SaaleGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
HELIOS Klinikum Krefeld GmbH
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KrefeldGermanyRecruiting
Johannes Gutenberg University Mainz
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MainzGermanyRecruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyRecruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyRecruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Aarhus University
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Aarhus NDenmarkRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Vall D'hebron Institut De Recerca
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BarcelonaSpainRecruiting
Hospital Infantil Universitario Nino Jesus
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MadridSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
HUS
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HelsinkiFinlandRecruiting
Kuopio University Hospital
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KuopioFinlandRecruiting
Oulu University Hospital
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OuluFinlandRecruiting
TAYS Sydaenkeskus Oy
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TampereFinlandRecruiting
University Of Turku
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TurkuFinlandRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Besancon University Hospital Center
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Besancon CedexFranceRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Hospices Civils de Lyon
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LyonFranceRecruiting
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Centre Hospitalier Universitaire Reims
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ReimsFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
CHU De Rouen
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Rouen CedexFranceRecruiting
Centre Hospitalier Universitaire De Saint Etienne
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St Etienne Cedex 2FranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceRecruiting
Nosokomeio Paidon I Agia Sofia
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AthensGreeceRecruiting
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
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AthensGreeceRecruiting
University General Hospital of Heraklion
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HeraklionGreeceRecruiting
Mitera S.A.
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MarousiGreeceRecruiting
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceRecruiting
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceRecruiting
Semmelweis University
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BudapestHungaryRecruiting
University of Pecs
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PécsHungaryRecruiting
Children's Health Ireland
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DublinIrelandRecruiting
Schneider Childrens Medical Center
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Petah TikvaIsraelRecruiting
Azienda Ospedaliero-Universitaria delle Marche
Coordinator of this site? Confirm its status
AnconaItalyRecruiting
University Hospital Consorziale Policlinico
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BariItalyRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
ARNAS G. Brotzu
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CagliariItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyRecruiting
Azienda Ospedaliera-Universitaria Di Cosenza
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CosenzaItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
Giannina Gaslini Institute For Scientific Hospitalization And Care
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GenoaItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyRecruiting
L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
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NaplesItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Azienda Ospedale Universita Padova
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PadovaItalyRecruiting
ARNAS Civico Di Cristina Benfratelli
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PalermoItalyRecruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Coordinator of this site? Confirm its status
TriesteItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
University Of Verona Medical School
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VeronaItalyRecruiting
Chiba University Hospital
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ChibaJapanRecruiting
Ehime University Hospital
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EhimeJapanRecruiting
Hiroshima University Hospital
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HiroshimaJapanRecruiting
Hokkaido University Hospital
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HokkaidoJapanRecruiting
Hyogo Prefectural Kobe Childrens Hospital
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HyōgoJapanRecruiting
Kagoshima University Hospital
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KagoshimaJapanRecruiting
Kanagawa Childrens Medical Center
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KanagawaJapanRecruiting
Kyoto Prefectural University of Medicine
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KyotoJapanRecruiting
Kyoto University Hospital
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KyotoJapanRecruiting
Mie University Hospital
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MieJapanActive, not recruiting
Nagoya University Graduate School of Medicine
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NagoyaJapanRecruiting
Osaka City General Hospital
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OsakaJapanRecruiting
Osaka University Graduate School of Medicine 2-2
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OsakaJapanRecruiting
Saitama Prefectural Childrens Medical Center
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SaitamaJapanRecruiting
Shizuoka Childrens Hospital
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ShizuokaJapanRecruiting
Tohoku University Hospital
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TōhokuJapanRecruiting
National Center for Child Health and Development
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TokyoJapanRecruiting
The University of Tokyo Hospital
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TokyoJapanRecruiting
Tokyo Metropolitan Childre's Medical Center
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TokyoJapanActive, not recruiting
Nippon Medical School Hospital
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TokyoJapanRecruiting
Vilniaus universiteto ligonine Santaros klinikos VšĮ
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VilniusLithuaniaSuspended
Princess Máxima Center for Pediatric Oncology
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UtrechtNetherlandsRecruiting
Helse Bergen HF
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BergenNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
University Hospital Of North Norway HF
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TromsoeNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Starship Children's Hospital
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AucklandNew ZealandRecruiting
Christchurch Children's Hospital
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ChristchurchNew ZealandRecruiting
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej
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BialystokPolandCompleted
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
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BydgoszczPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
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ChorzówPolandCompleted
Uniwersytecki Szpital Dzieciecy W Krakowie
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CracowPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandCompleted
Wojewodzki Szpital Zespolony W Kielcach SPZOZ
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KielcePolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Uniwersytecki Szpital Dziecięcy w Lublinie
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LublinPolandCompleted
Wojewódzki Szpital Specjalistyczny w Olsztynie
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OlsztynPolandCompleted
Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
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PoznanPolandCompleted
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie
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RzeszówPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
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SzczecinPolandCompleted
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandCompleted
Centro Hospitalar E Universitărio de Coimbra E.P.E.
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CoimbraPortugalRecruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
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LisbonPortugalRecruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalRecruiting
Jeddah-King Abdulaziz Medical City
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JeddahSaudi ArabiaActive, not recruiting
King Abdulaziz Medical City, King Abdullah International Medical Research Center
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RiyadhSaudi ArabiaRecruiting
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
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GothenburgSwedenRecruiting
Linkoping University Hospital Region Ostergotland
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LinkopingSwedenRecruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenRecruiting
Karolinska University Hospital
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StockholmSwedenRecruiting
Norrlands University Hospital
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UmeåSwedenRecruiting
Uppsala University Hospital
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UppsalaSwedenRecruiting
Narodny ustav detskych chorob
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BratislavaSlovakiaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.