RecruitingPhase 3NCT05327894

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.


Sponsor

Princess Maxima Center for Pediatric Oncology

Enrollment

160 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 DayMax Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is testing an intensive treatment protocol — including a drug called blinatumomab — for infants under one year old diagnosed with a specific type of aggressive leukemia involving a gene rearrangement called KMT2A. **You may be eligible if...** - Your baby has been newly diagnosed with B-cell acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia (MPAL) - The leukemia involves a KMT2A gene rearrangement - Your baby is 365 days old or younger at the time of diagnosis - A parent or legal guardian provides written informed consent **You may NOT be eligible if...** - Your baby has Down syndrome - The leukemia has already relapsed - Your baby received systemic steroids or chemotherapy in the 4 weeks before diagnosis (babies on inhaled steroids may still qualify) - The leukemia is T-cell type or multilineage MPAL Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBlinatumomab

1st cycle: 15 μg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 μg/m2/day in week 1 followed by 15 μg/m2/day in weeks 2, 3, and 4.

DRUGBlinatumomab

2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion


Locations(115)

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

Buenos Aires, Argentina

Australian and New Zealand Children's Haematology/Oncology Group

Clayton, Victoria, Australia

North Adelaide- Womens and Childrens Hospital

Adelaide, Australia

Monash Children's Hosptial

Clayton, Australia

New Lambton Heights- John Hunter Children's Hospital

New Lambton Heights, Australia

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

Parkville, Australia

Perth Children's Hospital

Perth, Australia

Queensland Children's Hospital

South Brisbane, Australia

Sydney Childrens Hospital

Sydney, Australia

The Childrens Hospital at Westmead

Westmead, Australia

Medical University Of Graz

Graz, Austria

Medical University Of Innsbruck

Innsbruck, Austria

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Salzburg, Austria

St. Anna Children's Hospital

Vienna, Austria

Antwerp University Hospital

Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Regional De La Citadelle

Liège, Belgium

CHC MontLegia

Liège, Belgium

University Hospital Brno

Brno, Czechia

University Hospital Olomouc

Olomouc, Czechia

Hospital Motol V Uvalu 841

Prague, Czechia

AUH Skejby

Aarhus, Denmark

Copenhagen-Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

New Children's Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

CHU Amiens

Amiens, France

CHU Besancon

Besançon, France

CHU de Bordeaux

Bordeaux, France

HCE

Grenoble, France

CHRU de Lille

Lille, France

Institute of Hematology and Pediatric Oncology

Lyon, France

CHU Timone

Marseille, France

CHI Montpellier

Montpellier, France

CHU Nancy

Nancy, France

CHU Nantes

Nantes, France

CHU de Nice

Nice, France

Hôpital Robert Debré, APHP

Paris, France

TRS

Paris, France

CHU Reims

Reims, France

CHU Rennes

Rennes, France

CHU Charles Nicolle

Rouen, France

CHRU Strasbourg Hautepierre

Strasbourg, France

Universitätsklinikum Augsburg

Augsburg, Germany

Charite Universitaetsmedizin Berlin KöR

Berlin, Germany

Universitaetsklinikum Bonn AöR

Bonn, Germany

Klinikum Dortmund gGmbH

Dortmund, Germany

Universitaetsklinikum Erlangen AöR

Erlangen, Germany

Justus-Liebig-Universitaet Giessen

Giessen, Germany

Universitaetsklinikum Halle (Saale) AöR

Halle, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Universtitätsklinikum Eppendorf

Hamburg, Germany

Universitätsklinikum Heidelberg AöR

Heidelberg, Germany

Universitaetsklinikum Schleswig-Holstein AöR

Kiel, Germany

HELIOS Klinikum Krefeld GmbH

Krefeld, Germany

Johannes Gutenberg University Mainz

Mainz, Germany

Universitaetsklinikum Muenster AöR

Münster, Germany

Klinikum Der Landeshauptstadt Stuttgart gKAöR

Stuttgart, Germany

Universitaetsklinikum Tuebingen AöR

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Aghia Sophia' Children's Hospital

Athens, Greece

HeSPHO

Athens, Greece

University General Hospital Of Heraklion

Heraklion, Greece

Mitera

Marousi, Greece

University Semmelweis

Budapest, Hungary

University of Pécs

Pécs, Hungary

National Children's Cancer Service

Dublin, Ireland

Schneider Childrens Medical Center

Petah Tikva, Israel

L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon

Naples, Italy

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, Italy

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

Trieste, Italy

University Of Verona Medical School

Verona, Italy

Chiba University Hospital

Chiba, Japan

Ehime University Hospital

Ehime, Japan

Hiroshima University Hospital

Hiroshima, Japan

Hokkaido University Hospital

Hokkaido, Japan

Hyogo Prefectural Kobe Childrens Hospital

Hyōgo, Japan

Kagoshima University Hospital

Kagoshima, Japan

Kanagawa Childrens Medical Center

Kanagawa, Japan

Kyoto Prefectural University of Medicine

Kyoto, Japan

Kyoto University Hospital

Kyoto, Japan

Mie University Hospital

Mie, Japan

Nagoya University Graduate School of Medicine

Nagoya, Japan

Osaka City General Hospital

Osaka, Japan

Osaka University Graduate School of Medicine 2-2

Osaka, Japan

Saitama Prefectural Childrens Medical Center

Saitama, Japan

Shizuoka Childrens Hospital

Shizuoka, Japan

National Center for Child Health and Development

Tokyo, Japan

The University of Tokyo Hospital

Tokyo, Japan

Tokyo Metropolitan Childre's Medical Center

Tokyo, Japan

Tohoku University Hospital

Tōhoku, Japan

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Princess Máxima Center for pediatric oncology

Utrecht, Utrecht, Netherlands

Christchurch Children's Hospital

Christchurch, New Zealand

Haukeland University Hospital

Bergen, Norway

St. Olavs Hospital

Trondheim, Norway

Instituto Portugues de Oncologica Lisboa

Lisbon, Portugal

Jeddah-King Abdulaziz Medical City

Jeddah, Saudi Arabia

King Abdulaziz Medical City, King Abdullah International Medical Research Center

Riyadh, Saudi Arabia

National Institute of Children's Diseases

Bratislava, Slovakia

Vall D'hebron Institut De Recerca

Barcelona, Spain

Hospital Infantil Universitario Nino Jesus

Madrid, Spain

University Hospital Virgen Del Rocio S.L.

Seville, Spain

Hospital Universitario Y Politecnico La Fe

Valencia, Spain

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

Gothenburg, Sweden

Linkoping University Hospital

Linköping, Sweden

Skane University Hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

Umea University Hospital

Umeå, Sweden

Children's UH

Uppsala, Sweden

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NCT05327894


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