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

Last updated: January 6, 2026
Sponsor: Princess Maxima Center for Pediatric Oncology
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphocytic Leukemia, Acute

Platelet Disorders

Leukemia

Treatment

Blinatumomab

Clinical Study ID

NCT05327894
2021-000213-16
  • Ages 1-1
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. ≤ 365 days of age at the time of diagnosis of ALL.

  3. Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.

Exclusion criteria for blinatumomab:

  1. KMT2A-wildtype patients.

  2. Multilineage MPAL

  3. T-ALL.

  4. Age > 365 days at the time of diagnosis.

  5. Down syndrome.

  6. Relapsed ALL.

  7. 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.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Blinatumomab
Phase: 3
Study Start date:
December 15, 2022
Estimated Completion Date:
September 30, 2030

Study Description

All infants that are eligible for this study and for whom the parents/legal representatives give informed consent will be enrolled in this study. All patients will receive one cycle of blinatumomab on top of the standard treatment backbone after induction therapy. Medium risk patients, that respond well to the 1st cycle will be treated with a 2nd cycle of blinatumomab replacing one chemo course after consolidation therapy. If they do not respond well enough they will be treated according to the current treatment standard. Minimal residual disease will be used to determine the response to blinatumomab. High risk patients will be eligible for allogeneic stem cell transplantation after the first blinatumomab cycle if they are Minimal Residual Disease (MRD) negative (defined as < 0.01%). Also medium risk patients with insufficient MRD response after induction or after the 1st cycle of blinatumomab will be allocated to high risk treatment and will be eligible for allogeneic stem cell transplantation.

Connect with a study center

  • Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"

    Buenos Aires 3435910,
    Argentina

    Active - Recruiting

  • Australian and New Zealand Children's Haematology/Oncology Group

    Clayton, Victoria
    Australia

    Site Not Available

  • Australian and New Zealand Children's Haematology/Oncology Group

    Clayton 2171400, Victoria 2145234
    Australia

    Site Not Available

  • North Adelaide- Womens and Childrens Hospital

    Adelaide,
    Australia

    Site Not Available

  • North Adelaide- Womens and Childrens Hospital

    Adelaide 2078025,
    Australia

    Site Not Available

  • Monash Children's Hosptial

    Clayton,
    Australia

    Site Not Available

  • Monash Children's Hosptial

    Clayton 2171400,
    Australia

    Site Not Available

  • New Lambton Heights- John Hunter Children's Hospital

    New Lambton Heights,
    Australia

    Site Not Available

  • New Lambton Heights- John Hunter Children's Hospital

    New Lambton Heights 10103866,
    Australia

    Site Not Available

  • Royal Children's Hospital (Children's Cancer Centre)

    Parkville,
    Australia

    Site Not Available

  • Royal Children's Hospital (Children's Cancer Centre)

    Parkville 2153770,
    Australia

    Site Not Available

  • Perth Children's Hospital

    Perth,
    Australia

    Site Not Available

  • Perth Children's Hospital

    Perth 2063523,
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane,
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane 2207259,
    Australia

    Site Not Available

  • Sydney Childrens Hospital

    Sydney,
    Australia

    Site Not Available

  • Sydney Childrens Hospital

    Sydney 2147714,
    Australia

    Site Not Available

  • The Childrens Hospital at Westmead

    Westmead,
    Australia

    Site Not Available

  • The Childrens Hospital at Westmead

    Westmead 2143973,
    Australia

    Site Not Available

  • Medical University Of Graz

    Graz 2778067,
    Austria

    Site Not Available

  • Medical University Of Innsbruck

    Innsbruck 2775220,
    Austria

    Site Not Available

  • Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

    Salzburg 2766824,
    Austria

    Site Not Available

  • St. Anna Children's Hospital

    Vienna,
    Austria

    Site Not Available

  • St. Anna Children's Hospital

    Vienna 2761369,
    Austria

    Site Not Available

  • Antwerp University Hospital

    Antwerp,
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Antwerp 2803138,
    Belgium

    Site Not Available

  • Hôpital Universitaire des Enfants Reine Fabiola

    Brussel,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels 2800866,
    Belgium

    Site Not Available

  • Hôpital Universitaire des Enfants Reine Fabiola

    Brussels 2800866,
    Belgium

    Site Not Available

  • Centre Hospitalier Regional De La Citadelle

    Citadelle Luik,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Ghent,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Ghent 2797656,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482,
    Belgium

    Site Not Available

  • CHC MontLegia

    Liège,
    Belgium

    Site Not Available

  • Centre Hospitalier Regional De La Citadelle

    Liège,
    Belgium

    Site Not Available

  • CHC MontLegia

    Liège 2792413,
    Belgium

    Site Not Available

  • Centre Hospitalier Regional De La Citadelle

    Liège 2792413,
    Belgium

    Site Not Available

  • CHC MontLegia

    Montlegia Luik,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    St Luc Sint-Lambrechts,
    Belgium

    Site Not Available

  • University Hospital Olomouc

    Olomouc,
    Czech Republic

    Active - Recruiting

  • University Hospital Brno

    Brno,
    Czechia

    Site Not Available

  • University Hospital Brno

    Brno 3078610,
    Czechia

    Site Not Available

  • University Hospital Olomouc

    Olomouc,
    Czechia

    Site Not Available

  • University Hospital Olomouc

    Olomouc 3069011,
    Czechia

    Site Not Available

  • Hospital Motol V Uvalu 841

    Prague,
    Czechia

    Site Not Available

  • Hospital Motol V Uvalu 841

    Prague 3067696,
    Czechia

    Site Not Available

  • AUH Skejby

    Aarhus,
    Denmark

    Site Not Available

  • AUH Skejby

    Aarhus 2624652,
    Denmark

    Site Not Available

  • Copenhagen-Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Copenhagen-Rigshospitalet

    Copenhagen 2618425,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense 2615876,
    Denmark

    Site Not Available

  • New Children's Hospital

    Helsinki,
    Finland

    Site Not Available

  • New Children's Hospital

    Helsinki 658225,
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio,
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio 650224,
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu,
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu 643492,
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere,
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere 634963,
    Finland

    Site Not Available

  • CHU Besancon

    Besancon,
    France

    Site Not Available

  • CHU Besancon

    Besançon 3033123,
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux 3031582,
    France

    Site Not Available

  • HCE

    Grenoble 3014728,
    France

    Site Not Available

  • CHRU de Lille

    Lille 2998324,
    France

    Site Not Available

  • Institute of Hematology and Pediatric Oncology

    Lyon,
    France

    Site Not Available

  • Institute of Hematology and Pediatric Oncology

    Lyon 2996944,
    France

    Site Not Available

  • CHU Timone

    Marseille 2995469,
    France

    Site Not Available

  • CHI Montpellier

    Montpellier 2992166,
    France

    Site Not Available

  • CHU Nancy

    Nancy 2990999,
    France

    Site Not Available

  • CHU Nantes

    Nantes 2990969,
    France

    Site Not Available

  • CHU de Nice

    Nice 2990440,
    France

    Site Not Available

  • Hôpital Robert Debré, APHP

    Paris,
    France

    Site Not Available

  • Hôpital Robert Debré, APHP

    Paris 2988507,
    France

    Site Not Available

  • TRS

    Paris 2988507,
    France

    Site Not Available

  • CHU Reims

    Reims 2984114,
    France

    Site Not Available

  • CHU Rennes

    Rennes 2983990,
    France

    Site Not Available

  • CHU Charles Nicolle

    Rouen,
    France

    Site Not Available

  • CHU Charles Nicolle

    Rouen 2982652,
    France

    Site Not Available

  • CHRU Strasbourg Hautepierre

    Strasbourg 2973783,
    France

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg,
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg 2954172,
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin KöR

    Berlin,
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin KöR

    Berlin 2950159,
    Germany

    Site Not Available

  • Universitaetsklinikum Bonn AöR

    Bonn 2946447,
    Germany

    Site Not Available

  • Klinikum Dortmund gGmbH

    Dortmund,
    Germany

    Site Not Available

  • Klinikum Dortmund gGmbH

    Dortmund 2935517,
    Germany

    Site Not Available

  • Universitaetsklinikum Erlangen AöR

    Erlangen 2929567,
    Germany

    Site Not Available

  • Justus-Liebig-Universitaet Giessen

    Giessen,
    Germany

    Site Not Available

  • Justus-Liebig-Universitaet Giessen

    Giessen 2920512,
    Germany

    Site Not Available

  • Universitaetsklinikum Halle (Saale) AöR

    Halle,
    Germany

    Site Not Available

  • Universitaetsklinikum Halle (Saale) AöR

    Halle 2911522,
    Germany

    Site Not Available

  • University Medical Center Hamburg-Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • Universtitätsklinikum Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • University Medical Center Hamburg-Eppendorf

    Hamburg 2911298,
    Germany

    Site Not Available

  • Universtitätsklinikum Eppendorf

    Hamburg 2911298,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg AöR

    Heidelberg,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg AöR

    Heidelberg 2907911,
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein AöR

    Kiel,
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein AöR

    Kiel 2891122,
    Germany

    Site Not Available

  • HELIOS Klinikum Krefeld GmbH

    Krefeld,
    Germany

    Site Not Available

  • HELIOS Klinikum Krefeld GmbH

    Krefeld 2884509,
    Germany

    Site Not Available

  • Johannes Gutenberg University Mainz

    Mainz 2874225,
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster AöR

    Munster,
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster AöR

    Münster 2867543,
    Germany

    Site Not Available

  • Klinikum Der Landeshauptstadt Stuttgart gKAöR

    Stuttgart,
    Germany

    Site Not Available

  • Klinikum Der Landeshauptstadt Stuttgart gKAöR

    Stuttgart 2825297,
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen AöR

    Tuebingen,
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen AöR

    Tübingen 2820860,
    Germany

    Site Not Available

  • Aghia Sophia' Children's Hospital

    Athens,
    Greece

    Site Not Available

  • HeSPHO

    Athens,
    Greece

    Site Not Available

  • Aghia Sophia' Children's Hospital

    Athens 264371,
    Greece

    Site Not Available

  • HeSPHO

    Athens 264371,
    Greece

    Site Not Available

  • University General Hospital Of Heraklion

    Heraklion,
    Greece

    Site Not Available

  • University General Hospital Of Heraklion

    Heraklion 261745,
    Greece

    Site Not Available

  • Mitera

    Marousi,
    Greece

    Site Not Available

  • Mitera

    Marousi 265243,
    Greece

    Site Not Available

  • University Semmelweis

    Budapest,
    Hungary

    Site Not Available

  • University Semmelweis

    Budapest 3054643,
    Hungary

    Site Not Available

  • University of Pécs

    Pécs,
    Hungary

    Site Not Available

  • University of Pécs

    Pécs 3046526,
    Hungary

    Site Not Available

  • National Children's Cancer Service

    Dublin,
    Ireland

    Site Not Available

  • OLCH Crumlin

    Dublin,
    Ireland

    Site Not Available

  • National Children's Cancer Service

    Dublin 2964574,
    Ireland

    Site Not Available

  • L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon

    Napoli,
    Italy

    Site Not Available

  • L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon

    Napoli 9031661,
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesù

    Roma,
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesù

    Roma 8957247,
    Italy

    Site Not Available

  • Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

    Trieste 3165185,
    Italy

    Site Not Available

  • University Of Verona Medical School

    Verona 3164527,
    Italy

    Site Not Available

  • Chiba University Hospital

    Chiba,
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba 2113015,
    Japan

    Site Not Available

  • Ehime University Hospital

    Ehime,
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima,
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima 1862415,
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Hokkaido,
    Japan

    Site Not Available

  • Hyogo Prefectural Kobe Childrens Hospital

    Hyogo,
    Japan

    Site Not Available

  • Hyogo Prefectural Kobe Childrens Hospital

    Hyōgo 2129969,
    Japan

    Site Not Available

  • Kagoshima University Hospital

    Kagoshima,
    Japan

    Site Not Available

  • Kagoshima University Hospital

    Kagoshima 1860827,
    Japan

    Site Not Available

  • Kanagawa Childrens Medical Center

    Kanagawa,
    Japan

    Site Not Available

  • Kanagawa Childrens Medical Center

    Kanagawa 1860292,
    Japan

    Site Not Available

  • Kyoto Prefectural University of Medicine

    Kyoto,
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto,
    Japan

    Site Not Available

  • Kyoto Prefectural University of Medicine

    Kyoto 1857910,
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto 1857910,
    Japan

    Site Not Available

  • Mie University Hospital

    Mie,
    Japan

    Site Not Available

  • Mie University Hospital

    Mie 1857357,
    Japan

    Site Not Available

  • Nagoya University Graduate School of Medicine

    Nagoya,
    Japan

    Site Not Available

  • Nagoya University Graduate School of Medicine

    Nagoya 1856057,
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka,
    Japan

    Site Not Available

  • Osaka University Graduate School of Medicine 2-2

    Osaka,
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka 1853909,
    Japan

    Site Not Available

  • Osaka University Graduate School of Medicine 2-2

    Osaka 1853909,
    Japan

    Site Not Available

  • Saitama Prefectural Childrens Medical Center

    Saitama,
    Japan

    Site Not Available

  • Saitama Prefectural Childrens Medical Center

    Saitama 6940394,
    Japan

    Site Not Available

  • Shizuoka Childrens Hospital

    Shizuoka,
    Japan

    Site Not Available

  • Shizuoka Childrens Hospital

    Shizuoka 1851717,
    Japan

    Site Not Available

  • Tohoku University Hospital

    Tohoku,
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Tokyo,
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Tokyo,
    Japan

    Site Not Available

  • Tokyo Metropolitan Childre&#39;s Medical Center

    Tokyo,
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Tokyo 1850147,
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Tokyo 1850147,
    Japan

    Site Not Available

  • Tokyo Metropolitan Childre&#39;s Medical Center

    Tokyo 1850147,
    Japan

    Site Not Available

  • Tohoku University Hospital

    Tōhoku 11010639,
    Japan

    Site Not Available

  • Vilnius University Hospital Santaros Klinikos

    Vilnius,
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santaros Klinikos

    Vilnius 593116,
    Lithuania

    Site Not Available

  • Princess Máxima Center for pediatric oncology

    Utrecht 2745912, Utrecht 2745909 3584 CS
    Netherlands

    Site Not Available

  • Princess Máxima Center for pediatric oncology

    Utrecht, 3584 CS
    Netherlands

    Site Not Available

  • Christchurch Children's Hospital

    Christchurch 2192362,
    New Zealand

    Site Not Available

  • Haukeland University Hospital

    Bergen,
    Norway

    Site Not Available

  • Haukeland University Hospital

    Bergen 3161732,
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim,
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim 3133880,
    Norway

    Site Not Available

  • Instituto Portugues de Oncologica Lisboa

    Lisboa,
    Portugal

    Site Not Available

  • Instituto Portugues de Oncologica Lisboa

    Lisbon 2267057,
    Portugal

    Site Not Available

  • Jeddah-King Abdulaziz Medical City

    Jeddah,
    Saudi Arabia

    Site Not Available

  • Jeddah-King Abdulaziz Medical City

    Jeddah 105343,
    Saudi Arabia

    Site Not Available

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

    Riyadh,
    Saudi Arabia

    Site Not Available

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

    Riyadh 108410,
    Saudi Arabia

    Site Not Available

  • National Institute of Children's Diseases

    Bratislava,
    Slovakia

    Site Not Available

  • National Institute of Children's Diseases

    Bratislava 3060972,
    Slovakia

    Site Not Available

  • Vall D'hebron Institut De Recerca

    Barcelona,
    Spain

    Site Not Available

  • Vall D'hebron Institut De Recerca

    Barcelona 3128760,
    Spain

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus

    Madrid,
    Spain

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus

    Madrid 3117735,
    Spain

    Site Not Available

  • University Hospital Virgen Del Rocio S.L.

    Sevilla,
    Spain

    Site Not Available

  • University Hospital Virgen Del Rocio S.L.

    Seville 2510911,
    Spain

    Site Not Available

  • Hospital Universitario Y Politecnico La Fe

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitario Y Politecnico La Fe

    Valencia 2509954,
    Spain

    Site Not Available

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

    Gothenburg,
    Sweden

    Site Not Available

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

    Gothenburg 2711537,
    Sweden

    Site Not Available

  • Linkoping University Hospital

    Linkoping,
    Sweden

    Site Not Available

  • Linkoping University Hospital

    Linköping 2694762,
    Sweden

    Site Not Available

  • Skane University Hospital

    Lund,
    Sweden

    Site Not Available

  • Skane University Hospital

    Lund 2693678,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm 2673730,
    Sweden

    Site Not Available

  • Umea University Hospital

    Umea,
    Sweden

    Site Not Available

  • Umea University Hospital

    Umeå 602150,
    Sweden

    Site Not Available

  • Children's UH

    Uppsala 2666199,
    Sweden

    Site Not Available

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