Actively Recruiting
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2026-04-13
160
Participants Needed
115
Research Sites
402 weeks
Total Duration
On this page
Sponsors
P
Princess Maxima Center for Pediatric Oncology
Lead Sponsor
U
University of Milano Bicocca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of newly diagnosed B-precursor ALL or B-cell mixed phenotype acute leukemia with KMT2A-rearrangement
- Age 365 days or younger at time of diagnosis
- Written informed consent from parent(s) or legal guardian according to local laws
You will not qualify if you...
- Patients without KMT2A rearrangement (KMT2A-wildtype)
- Multilineage mixed phenotype acute leukemia
- T-cell acute lymphoblastic leukemia
- Age older than 365 days at diagnosis
- Diagnosis of Down syndrome
- Relapsed acute lymphoblastic leukemia
- Treatment with systemic corticosteroids over 10 mg/m2/day for more than one week or chemotherapy within 4 weeks before diagnosis (aerosol corticosteroids allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 115 locations
1
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"
Buenos Aires, Argentina
Suspended
2
Australian and New Zealand Children's Haematology/Oncology Group
Clayton, Victoria, Australia
Actively Recruiting
3
North Adelaide- Womens and Childrens Hospital
Adelaide, Australia
Active, Not Recruiting
4
Monash Children's Hosptial
Clayton, Australia
Active, Not Recruiting
5
New Lambton Heights- John Hunter Children's Hospital
New Lambton Heights, Australia
Active, Not Recruiting
6
Royal Children's Hospital (Children's Cancer Centre)
Parkville, Australia
Active, Not Recruiting
7
Perth Children's Hospital
Perth, Australia
Actively Recruiting
8
Queensland Children's Hospital
South Brisbane, Australia
Active, Not Recruiting
9
Sydney Childrens Hospital
Sydney, Australia
Active, Not Recruiting
10
The Childrens Hospital at Westmead
Westmead, Australia
Active, Not Recruiting
11
Medical University Of Graz
Graz, Austria
Active, Not Recruiting
12
Medical University Of Innsbruck
Innsbruck, Austria
Actively Recruiting
13
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Salzburg, Austria
Actively Recruiting
14
St. Anna Children's Hospital
Vienna, Austria
Actively Recruiting
15
Antwerp University Hospital
Antwerp, Belgium
Active, Not Recruiting
16
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Active, Not Recruiting
17
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium
Active, Not Recruiting
18
Universitair Ziekenhuis Gent
Ghent, Belgium
Active, Not Recruiting
19
UZ Leuven
Leuven, Belgium
Active, Not Recruiting
20
Centre Hospitalier Regional De La Citadelle
Liège, Belgium
Active, Not Recruiting
21
CHC MontLegia
Liège, Belgium
Active, Not Recruiting
22
University Hospital Brno
Brno, Czechia
Active, Not Recruiting
23
University Hospital Olomouc
Olomouc, Czechia
Active, Not Recruiting
24
Hospital Motol V Uvalu 841
Prague, Czechia
Actively Recruiting
25
AUH Skejby
Aarhus, Denmark
Actively Recruiting
26
Copenhagen-Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
27
Odense University Hospital
Odense, Denmark
Active, Not Recruiting
28
New Children's Hospital
Helsinki, Finland
Active, Not Recruiting
29
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
30
Oulu University Hospital
Oulu, Finland
Active, Not Recruiting
31
Tampere University Hospital
Tampere, Finland
Actively Recruiting
32
CHU Amiens
Amiens, France
Actively Recruiting
33
CHU Besancon
Besançon, France
Active, Not Recruiting
34
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
35
HCE
Grenoble, France
Active, Not Recruiting
36
CHRU de Lille
Lille, France
Active, Not Recruiting
37
Institute of Hematology and Pediatric Oncology
Lyon, France
Active, Not Recruiting
38
CHU Timone
Marseille, France
Active, Not Recruiting
39
CHI Montpellier
Montpellier, France
Active, Not Recruiting
40
CHU Nancy
Nancy, France
Active, Not Recruiting
41
CHU Nantes
Nantes, France
Active, Not Recruiting
42
CHU de Nice
Nice, France
Active, Not Recruiting
43
Hôpital Robert Debré, APHP
Paris, France
Active, Not Recruiting
44
TRS
Paris, France
Actively Recruiting
45
CHU Reims
Reims, France
Actively Recruiting
46
CHU Rennes
Rennes, France
Actively Recruiting
47
CHU Charles Nicolle
Rouen, France
Active, Not Recruiting
48
CHRU Strasbourg Hautepierre
Strasbourg, France
Active, Not Recruiting
49
Universitätsklinikum Augsburg
Augsburg, Germany
Active, Not Recruiting
50
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Actively Recruiting
51
Universitaetsklinikum Bonn AöR
Bonn, Germany
Active, Not Recruiting
52
Klinikum Dortmund gGmbH
Dortmund, Germany
Actively Recruiting
53
Universitaetsklinikum Erlangen AöR
Erlangen, Germany
Active, Not Recruiting
54
Justus-Liebig-Universitaet Giessen
Giessen, Germany
Active, Not Recruiting
55
Universitaetsklinikum Halle (Saale) AöR
Halle, Germany
Active, Not Recruiting
56
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
57
Universtitätsklinikum Eppendorf
Hamburg, Germany
Active, Not Recruiting
58
Universitätsklinikum Heidelberg AöR
Heidelberg, Germany
Active, Not Recruiting
59
Universitaetsklinikum Schleswig-Holstein AöR
Kiel, Germany
Active, Not Recruiting
60
HELIOS Klinikum Krefeld GmbH
Krefeld, Germany
Active, Not Recruiting
61
Johannes Gutenberg University Mainz
Mainz, Germany
Active, Not Recruiting
62
Universitaetsklinikum Muenster AöR
Münster, Germany
Active, Not Recruiting
63
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany
Actively Recruiting
64
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany
Active, Not Recruiting
65
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
66
Aghia Sophia' Children's Hospital
Athens, Greece
Active, Not Recruiting
67
HeSPHO
Athens, Greece
Active, Not Recruiting
68
University General Hospital Of Heraklion
Heraklion, Greece
Active, Not Recruiting
69
Mitera
Marousi, Greece
Active, Not Recruiting
70
University Semmelweis
Budapest, Hungary
Active, Not Recruiting
71
University of Pécs
Pécs, Hungary
Actively Recruiting
72
National Children's Cancer Service
Dublin, Ireland
Actively Recruiting
73
Schneider Childrens Medical Center
Petah Tikva, Israel
Actively Recruiting
74
L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
Naples, Italy
Actively Recruiting
75
IRCCS Ospedale Pediatrico Bambino Gesù
Roma, Italy
Actively Recruiting
76
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Trieste, Italy
Actively Recruiting
77
University Of Verona Medical School
Verona, Italy
Actively Recruiting
78
Chiba University Hospital
Chiba, Japan
Active, Not Recruiting
79
Ehime University Hospital
Ehime, Japan
Active, Not Recruiting
80
Hiroshima University Hospital
Hiroshima, Japan
Active, Not Recruiting
81
Hokkaido University Hospital
Hokkaido, Japan
Active, Not Recruiting
82
Hyogo Prefectural Kobe Childrens Hospital
Hyōgo, Japan
Active, Not Recruiting
83
Kagoshima University Hospital
Kagoshima, Japan
Active, Not Recruiting
84
Kanagawa Childrens Medical Center
Kanagawa, Japan
Active, Not Recruiting
85
Kyoto Prefectural University of Medicine
Kyoto, Japan
Active, Not Recruiting
86
Kyoto University Hospital
Kyoto, Japan
Active, Not Recruiting
87
Mie University Hospital
Mie, Japan
Active, Not Recruiting
88
Nagoya University Graduate School of Medicine
Nagoya, Japan
Active, Not Recruiting
89
Osaka City General Hospital
Osaka, Japan
Active, Not Recruiting
90
Osaka University Graduate School of Medicine 2-2
Osaka, Japan
Active, Not Recruiting
91
Saitama Prefectural Childrens Medical Center
Saitama, Japan
Active, Not Recruiting
92
Shizuoka Childrens Hospital
Shizuoka, Japan
Active, Not Recruiting
93
National Center for Child Health and Development
Tokyo, Japan
Active, Not Recruiting
94
The University of Tokyo Hospital
Tokyo, Japan
Active, Not Recruiting
95
Tokyo Metropolitan Childre's Medical Center
Tokyo, Japan
Active, Not Recruiting
96
Tohoku University Hospital
Tōhoku, Japan
Active, Not Recruiting
97
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Active, Not Recruiting
98
Princess Máxima Center for pediatric oncology
Utrecht, Utrecht, Netherlands, 3584 CS
Actively Recruiting
99
Christchurch Children's Hospital
Christchurch, New Zealand
Active, Not Recruiting
100
Haukeland University Hospital
Bergen, Norway
Active, Not Recruiting
101
St. Olavs Hospital
Trondheim, Norway
Actively Recruiting
102
Instituto Portugues de Oncologica Lisboa
Lisbon, Portugal
Active, Not Recruiting
103
Jeddah-King Abdulaziz Medical City
Jeddah, Saudi Arabia
Active, Not Recruiting
104
King Abdulaziz Medical City, King Abdullah International Medical Research Center
Riyadh, Saudi Arabia
Active, Not Recruiting
105
National Institute of Children's Diseases
Bratislava, Slovakia
Active, Not Recruiting
106
Vall D'hebron Institut De Recerca
Barcelona, Spain
Actively Recruiting
107
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
Actively Recruiting
108
University Hospital Virgen Del Rocio S.L.
Seville, Spain
Active, Not Recruiting
109
Hospital Universitario Y Politecnico La Fe
Valencia, Spain
Active, Not Recruiting
110
Childrens Cancer Center Queen Silvia Children´s Hospital, Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
111
Linkoping University Hospital
Linköping, Sweden
Actively Recruiting
112
Skane University Hospital
Lund, Sweden
Active, Not Recruiting
113
Karolinska University Hospital
Stockholm, Sweden
Active, Not Recruiting
114
Umea University Hospital
Umeå, Sweden
Actively Recruiting
115
Children's UH
Uppsala, Sweden
Actively Recruiting
Research Team
L
Lieke van den Wildenberg
CONTACT
P
Peggy Scholte-Van Houtem
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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