Actively Recruiting

Phase 3
Age: 1Day - 1Year
All Genders
NCT05327894

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

Age: 1Day - 1Year
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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