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New hope for babies with aggressive leukemia: international trial launches

NCT ID NCT05327894

Disease control Sponsor: Princess Maxima Center for Pediatric Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a drug called blinatumomab in infants under 1 year old who have a specific, hard-to-treat type of leukemia (KMT2A-rearranged). The goal is to improve how long these babies stay cancer-free and to help them live longer. About 160 infants from around the world will take part, and the treatment is given alongside standard chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute biphenotypic leukemia acute lymphoblastic leukemia B-lymphoblastic leukemia/lymphoma with t(v;11q23.3) mixed phenotype acute leukemia mixed phenotype acute leukemia with t(v;11q23.3) Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia Mixed phenotype acute leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    93 sites in 21 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • AUH Skejby

    RECRUITING

    Aarhus, Denmark

  • Aghia Sophia' Children's Hospital

    ACTIVE_NOT_RECRUITING

    Athens, Greece

  • Antwerp University Hospital

    RECRUITING

    Antwerp, Belgium

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

    RECRUITING

    Clayton, Victoria, Australia

  • Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino

    RECRUITING

    Torino, Italy

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    RECRUITING

    Florence, Italy

  • CHC MontLegia

    RECRUITING

    Liège, Belgium

  • CHI Montpellier

    ACTIVE_NOT_RECRUITING

    Montpellier, France

  • CHRU Strasbourg Hautepierre

    RECRUITING

    Strasbourg, France

  • CHRU de Lille

    ACTIVE_NOT_RECRUITING

    Lille, France

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Besancon

    ACTIVE_NOT_RECRUITING

    Besançon, France

  • CHU Charles Nicolle

    RECRUITING

    Rouen, France

  • CHU Nancy

    RECRUITING

    Nancy, France

  • CHU Nantes

    RECRUITING

    Nantes, France

  • CHU Reims

    RECRUITING

    Reims, France

  • CHU Rennes

    RECRUITING

    Rennes, France

  • CHU Timone

    ACTIVE_NOT_RECRUITING

    Marseille, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU de Nice

    ACTIVE_NOT_RECRUITING

    Nice, France

  • Centre Hospitalier Regional De La Citadelle

    ACTIVE_NOT_RECRUITING

    Liège, Belgium

  • Centre Hospitalier Universitaire de Toulouse

    RECRUITING

    Toulouse, France

  • Charite Universitaetsmedizin Berlin KöR

    RECRUITING

    Berlin, Germany

  • Chiba University Hospital

    RECRUITING

    Chiba, Japan

  • Children's UH

    RECRUITING

    Uppsala, Sweden

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

    RECRUITING

    Gothenburg, Sweden

  • Christchurch Children's Hospital

    RECRUITING

    Christchurch, New Zealand

  • Cliniques Universitaires Saint-Luc

    ACTIVE_NOT_RECRUITING

    Brussels, Belgium

  • Copenhagen-Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • Ehime University Hospital

    RECRUITING

    Ehime, Japan

  • Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

    RECRUITING

    Salzburg, Austria

  • HCE

    ACTIVE_NOT_RECRUITING

    Grenoble, France

  • HELIOS Klinikum Krefeld GmbH

    ACTIVE_NOT_RECRUITING

    Krefeld, Germany

  • Haukeland University Hospital

    ACTIVE_NOT_RECRUITING

    Bergen, Norway

  • HeSPHO

    ACTIVE_NOT_RECRUITING

    Athens, Greece

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, Japan

  • Hokkaido University Hospital

    ACTIVE_NOT_RECRUITING

    Hokkaido, Japan

  • Hospital Infantil Universitario Nino Jesus

    RECRUITING

    Madrid, Spain

  • Hospital Motol V Uvalu 841

    RECRUITING

    Prague, Czechia

  • Hospital Universitario Y Politecnico La Fe

    RECRUITING

    Valencia, Spain

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

    SUSPENDED

    Buenos Aires, Argentina

  • Hyogo Prefectural Kobe Childrens Hospital

    ACTIVE_NOT_RECRUITING

    Hyōgo, Japan

  • Hôpital Robert Debré, APHP

    RECRUITING

    Paris, France

  • Hôpital Universitaire des Enfants Reine Fabiola

    RECRUITING

    Brussels, Belgium

  • IRCCS Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Roma, Italy

  • Institute of Hematology and Pediatric Oncology

    RECRUITING

    Lyon, France

  • Instituto Portugues de Oncologica Lisboa

    RECRUITING

    Lisbon, Portugal

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

    RECRUITING

    Trieste, Italy

  • Jeddah-King Abdulaziz Medical City

    ACTIVE_NOT_RECRUITING

    Jeddah, Saudi Arabia

  • Johannes Gutenberg University Mainz

    RECRUITING

    Mainz, Germany

  • Justus-Liebig-Universitaet Giessen

    RECRUITING

    Giessen, Germany

  • Kagoshima University Hospital

    RECRUITING

    Kagoshima, Japan

  • Kanagawa Childrens Medical Center

    RECRUITING

    Kanagawa, Japan

  • Karolinska University Hospital

    ACTIVE_NOT_RECRUITING

    Stockholm, Sweden

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

    ACTIVE_NOT_RECRUITING

    Riyadh, Saudi Arabia

  • Klinikum Der Landeshauptstadt Stuttgart gKAöR

    RECRUITING

    Stuttgart, Germany

  • Klinikum Dortmund gGmbH

    RECRUITING

    Dortmund, Germany

  • Klinikum rechts der Isar der TU Muenchen AöR

    RECRUITING

    München, Germany

  • Kuopio University Hospital

    RECRUITING

    Kuopio, Finland

  • Kyoto Prefectural University of Medicine

    RECRUITING

    Kyoto, Japan

  • Kyoto University Hospital

    RECRUITING

    Kyoto, Japan

  • L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon

    RECRUITING

    Naples, Italy

  • Linkoping University Hospital

    RECRUITING

    Linköping, Sweden

  • Medical University Of Graz

    RECRUITING

    Graz, Austria

  • Medical University Of Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Germany

  • Mie University Hospital

    ACTIVE_NOT_RECRUITING

    Mie, Japan

  • Mitera

    ACTIVE_NOT_RECRUITING

    Marousi, Greece

  • Monash Children's Hosptial

    ACTIVE_NOT_RECRUITING

    Clayton, Australia

  • Nagoya University Graduate School of Medicine

    RECRUITING

    Nagoya, Japan

  • National Center for Child Health and Development

    RECRUITING

    Tokyo, Japan

  • National Children's Cancer Service

    RECRUITING

    Dublin, Ireland

  • National Institute of Children's Diseases

    ACTIVE_NOT_RECRUITING

    Bratislava, Slovakia

  • New Children's Hospital

    RECRUITING

    Helsinki, Finland

  • New Lambton Heights- John Hunter Children's Hospital

    RECRUITING

    New Lambton Heights, Australia

  • Nippon Medical School Hospital

    RECRUITING

    Tokyo, Japan

  • North Adelaide- Womens and Childrens Hospital

    RECRUITING

    Adelaide, Australia

  • Odense University Hospital

    RECRUITING

    Odense, Denmark

  • Osaka City General Hospital

    RECRUITING

    Osaka, Japan

  • Osaka University Graduate School of Medicine 2-2

    RECRUITING

    Osaka, Japan

  • Oulu University Hospital

    ACTIVE_NOT_RECRUITING

    Oulu, Finland

  • Perth Children's Hospital

    RECRUITING

    Perth, Australia

  • Princess Máxima Center for pediatric oncology

    RECRUITING

    Utrecht, Utrecht, 3584 CS, Netherlands

    Contact Email: •••••@•••••

  • Queensland Children's Hospital

    ACTIVE_NOT_RECRUITING

    South Brisbane, Australia

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

    ACTIVE_NOT_RECRUITING

    Parkville, Australia

  • Saitama Prefectural Childrens Medical Center

    RECRUITING

    Saitama, Japan

  • Schneider Childrens Medical Center

    RECRUITING

    Petah Tikva, Israel

  • Shizuoka Childrens Hospital

    RECRUITING

    Shizuoka, Japan

  • Skane University Hospital

    ACTIVE_NOT_RECRUITING

    Lund, Sweden

  • St. Anna Children's Hospital

    RECRUITING

    Vienna, Austria

  • St. Olavs Hospital

    RECRUITING

    Trondheim, Norway

  • Starship Children's Hospital

    RECRUITING

    Auckland, New Zealand

  • Sydney Childrens Hospital

    RECRUITING

    Sydney, Australia

  • TRS

    RECRUITING

    Paris, France

  • Tampere University Hospital

    RECRUITING

    Tampere, Finland

  • The Childrens Hospital at Westmead

    RECRUITING

    Westmead, Australia

  • The University of Tokyo Hospital

    RECRUITING

    Tokyo, Japan

  • Tohoku University Hospital

    ACTIVE_NOT_RECRUITING

    Tōhoku, Japan

  • Tokyo Metropolitan Childre's Medical Center

    ACTIVE_NOT_RECRUITING

    Tokyo, Japan

  • Turku University Hospital

    RECRUITING

    Turku, Finland

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • Umea University Hospital

    RECRUITING

    Umeå, Sweden

  • Universitaetsklinikum Bonn AöR

    RECRUITING

    Bonn, Germany

  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

    RECRUITING

    Dresden, Germany

  • Universitaetsklinikum Erlangen AöR

    RECRUITING

    Erlangen, Germany

  • Universitaetsklinikum Halle (Saale) AöR

    RECRUITING

    Halle, Germany

  • Universitaetsklinikum Muenster AöR

    ACTIVE_NOT_RECRUITING

    Münster, Germany

  • Universitaetsklinikum Schleswig-Holstein AöR

    RECRUITING

    Kiel, Germany

  • Universitaetsklinikum Tuebingen AöR

    RECRUITING

    Tübingen, Germany

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, Belgium

  • University General Hospital Of Heraklion

    RECRUITING

    Heraklion, Greece

  • University Hospital Brno

    RECRUITING

    Brno, Czechia

  • University Hospital Olomouc

    ACTIVE_NOT_RECRUITING

    Olomouc, Czechia

  • University Hospital Virgen Del Rocio S.L.

    RECRUITING

    Seville, Spain

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • University Of Verona Medical School

    RECRUITING

    Verona, Italy

  • University Semmelweis

    RECRUITING

    Budapest, Hungary

  • University of Pécs

    RECRUITING

    Pécs, Hungary

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Germany

  • Universitätsklinikum Heidelberg AöR

    RECRUITING

    Heidelberg, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, Germany

  • Universtitätsklinikum Eppendorf

    ACTIVE_NOT_RECRUITING

    Hamburg, Germany

  • Vall D'hebron Institut De Recerca

    RECRUITING

    Barcelona, Spain

  • Vilnius University Hospital Santaros Klinikos

    ACTIVE_NOT_RECRUITING

    Vilnius, Lithuania

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