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

April 8, 2026 updated by: Princess Maxima Center for Pediatric Oncology

Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Suspended
        • Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"
  • Australia
      • Adelaide, Australia
        • Active, not recruiting
        • North Adelaide- Womens and Childrens Hospital
      • Clayton, Australia
        • Active, not recruiting
        • Monash Children's Hosptial
      • New Lambton Heights, Australia
        • Active, not recruiting
        • New Lambton Heights- John Hunter Children's Hospital
      • Parkville, Australia
        • Active, not recruiting
        • Royal Children's Hospital (Children's Cancer Centre)
      • Perth, Australia
        • Recruiting
        • Perth Children's Hospital
      • South Brisbane, Australia
        • Active, not recruiting
        • Queensland Children's Hospital
      • Sydney, Australia
        • Active, not recruiting
        • Sydney Childrens Hospital
      • Westmead, Australia
        • Active, not recruiting
        • The Childrens Hospital at Westmead
    • Victoria
      • Clayton, Victoria, Australia
        • Recruiting
        • Australian and New Zealand Children's Haematology/Oncology Group
  • Austria
      • Graz, Austria
        • Active, not recruiting
        • Medical University of Graz
      • Innsbruck, Austria
        • Recruiting
        • Medical University of Innsbruck
      • Salzburg, Austria
        • Recruiting
        • Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
      • Vienna, Austria
        • Recruiting
        • St. Anna Children's Hospital
  • Belgium
      • Antwerp, Belgium
        • Active, not recruiting
        • Antwerp University Hospital
      • Brussels, Belgium
        • Active, not recruiting
        • Hôpital Universitaire Des Enfants Reine Fabiola
      • Brussels, Belgium
        • Active, not recruiting
        • Cliniques universitaires Saint-Luc
      • Ghent, Belgium
        • Active, not recruiting
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • Active, not recruiting
        • UZ Leuven
      • Liège, Belgium
        • Active, not recruiting
        • Centre Hospitalier Régional de la Citadelle
      • Liège, Belgium
        • Active, not recruiting
        • CHC MontLegia
  • Czechia
      • Brno, Czechia
        • Active, not recruiting
        • University Hospital Brno
      • Olomouc, Czechia
        • Active, not recruiting
        • University Hospital Olomouc
      • Prague, Czechia
        • Recruiting
        • Hospital Motol V Uvalu 841
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • AUH Skejby
      • Copenhagen, Denmark
        • Recruiting
        • Copenhagen-Rigshospitalet
      • Odense, Denmark
        • Active, not recruiting
        • Odense University Hospital
  • Finland
      • Helsinki, Finland
        • Active, not recruiting
        • New Children's Hospital
      • Kuopio, Finland
        • Recruiting
        • Kuopio University Hospital
      • Oulu, Finland
        • Active, not recruiting
        • Oulu University Hospital
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
  • France
      • Amiens, France
        • Recruiting
        • CHU Amiens
      • Besançon, France
        • Active, not recruiting
        • CHU Besançon
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux
      • Grenoble, France
        • Active, not recruiting
        • HCE
      • Lille, France
        • Active, not recruiting
        • CHRU de Lille
      • Lyon, France
        • Active, not recruiting
        • Institute of Hematology and Pediatric Oncology
      • Marseille, France
        • Active, not recruiting
        • CHU Timone
      • Montpellier, France
        • Active, not recruiting
        • CHI Montpellier
      • Nancy, France
        • Active, not recruiting
        • CHU Nancy
      • Nantes, France
        • Active, not recruiting
        • Chu Nantes
      • Nice, France
        • Active, not recruiting
        • CHU de Nice
      • Paris, France
        • Active, not recruiting
        • Hôpital Robert Debré, APHP
      • Paris, France
        • Recruiting
        • TRS
      • Reims, France
        • Recruiting
        • CHU Reims
      • Rennes, France
        • Recruiting
        • CHU Rennes
      • Rouen, France
        • Active, not recruiting
        • CHU Charles Nicolle
      • Strasbourg, France
        • Active, not recruiting
        • CHRU Strasbourg Hautepierre
  • Germany
      • Augsburg, Germany
        • Active, not recruiting
        • Universitätsklinikum Augsburg
      • Berlin, Germany
        • Recruiting
        • Charite Universitaetsmedizin Berlin KöR
      • Bonn, Germany
        • Active, not recruiting
        • Universitaetsklinikum Bonn AöR
      • Dortmund, Germany
        • Recruiting
        • Klinikum Dortmund gGmbH
      • Erlangen, Germany
        • Active, not recruiting
        • Universitaetsklinikum Erlangen AöR
      • Giessen, Germany
        • Active, not recruiting
        • Justus-Liebig-Universitaet Giessen
      • Halle, Germany
        • Active, not recruiting
        • Universitaetsklinikum Halle (Saale) AöR
      • Hamburg, Germany
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
      • Hamburg, Germany
        • Active, not recruiting
        • Universtitätsklinikum Eppendorf
      • Heidelberg, Germany
        • Active, not recruiting
        • Universitätsklinikum Heidelberg AöR
      • Kiel, Germany
        • Active, not recruiting
        • Universitaetsklinikum Schleswig-Holstein AöR
      • Krefeld, Germany
        • Active, not recruiting
        • HELIOS Klinikum Krefeld GmbH
      • Mainz, Germany
        • Active, not recruiting
        • Johannes Gutenberg University Mainz
      • Münster, Germany
        • Active, not recruiting
        • Universitaetsklinikum Muenster AöR
      • Stuttgart, Germany
        • Recruiting
        • Klinikum Der Landeshauptstadt Stuttgart gKAöR
      • Tübingen, Germany
        • Active, not recruiting
        • Universitaetsklinikum Tuebingen AöR
      • Ulm, Germany
        • Recruiting
        • Universitätsklinikum Ulm
  • Greece
      • Athens, Greece
        • Active, not recruiting
        • Aghia Sophia' Children's Hospital
      • Athens, Greece
        • Active, not recruiting
        • HeSPHO
      • Heraklion, Greece
        • Active, not recruiting
        • University General Hospital of Heraklion
      • Marousi, Greece
        • Active, not recruiting
        • Mitera
  • Hungary
      • Budapest, Hungary
        • Active, not recruiting
        • University Semmelweis
      • Pécs, Hungary
        • Recruiting
        • University of Pecs
  • Ireland
      • Dublin, Ireland
        • Recruiting
        • National Children's Cancer Service
  • Israel
      • Petah Tikva, Israel
        • Recruiting
        • Schneider Childrens Medical Center
  • Italy
      • Naples, Italy
        • Recruiting
        • L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
      • Roma, Italy
        • Recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesù
      • Trieste, Italy
        • Recruiting
        • Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
      • Verona, Italy
        • Recruiting
        • University Of Verona Medical School
  • Japan
      • Chiba, Japan
        • Active, not recruiting
        • Chiba University Hospital
      • Ehime, Japan
        • Active, not recruiting
        • Ehime University Hospital
      • Hiroshima, Japan
        • Active, not recruiting
        • Hiroshima University Hospital
      • Hokkaido, Japan
        • Active, not recruiting
        • Hokkaido University Hospital
      • Hyōgo, Japan
        • Active, not recruiting
        • Hyogo Prefectural Kobe Childrens Hospital
      • Kagoshima, Japan
        • Active, not recruiting
        • Kagoshima University Hospital
      • Kanagawa, Japan
        • Active, not recruiting
        • Kanagawa Childrens Medical Center
      • Kyoto, Japan
        • Active, not recruiting
        • Kyoto Prefectural University of Medicine
      • Kyoto, Japan
        • Active, not recruiting
        • Kyoto University Hospital
      • Mie, Japan
        • Active, not recruiting
        • Mie University Hospital
      • Nagoya, Japan
        • Active, not recruiting
        • Nagoya University Graduate School of Medicine
      • Osaka, Japan
        • Active, not recruiting
        • Osaka City General Hospital
      • Osaka, Japan
        • Active, not recruiting
        • Osaka University Graduate School of Medicine 2-2
      • Saitama, Japan
        • Active, not recruiting
        • Saitama Prefectural Childrens Medical Center
      • Shizuoka, Japan
        • Active, not recruiting
        • Shizuoka Childrens Hospital
      • Tokyo, Japan
        • Active, not recruiting
        • National Center for Child Health and Development
      • Tokyo, Japan
        • Active, not recruiting
        • The University of Tokyo Hospital
      • Tokyo, Japan
        • Active, not recruiting
        • Tokyo Metropolitan Childre's Medical Center
      • Tōhoku, Japan
        • Active, not recruiting
        • Tohoku University Hospital
  • Lithuania
      • Vilnius, Lithuania
        • Active, not recruiting
        • Vilnius University Hospital Santaros Klinikos
  • Netherlands
  • New Zealand
      • Christchurch, New Zealand
        • Active, not recruiting
        • Christchurch Children's Hospital
  • Norway
      • Bergen, Norway
        • Active, not recruiting
        • Haukeland University Hospital
      • Trondheim, Norway
        • Recruiting
        • St. Olavs Hospital
  • Portugal
      • Lisbon, Portugal
        • Active, not recruiting
        • Instituto Portugues de Oncologica Lisboa
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Active, not recruiting
        • Jeddah-King Abdulaziz Medical City
      • Riyadh, Saudi Arabia
        • Active, not recruiting
        • King Abdulaziz Medical City, King Abdullah International Medical Research Center
  • Slovakia
      • Bratislava, Slovakia
        • Active, not recruiting
        • National Institute of Children's Diseases
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Vall D'hebron Institut De Recerca
      • Madrid, Spain
        • Recruiting
        • Hospital Infantil Universitario Nino Jesus
      • Seville, Spain
        • Active, not recruiting
        • University Hospital Virgen Del Rocio S.L.
      • Valencia, Spain
        • Active, not recruiting
        • Hospital Universitario y Politécnico La FE
  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Childrens Cancer Center Queen Silvia Children´s Hospital, Sahlgrenska University Hospital
      • Linköping, Sweden
        • Recruiting
        • Linköping University Hospital
      • Lund, Sweden
        • Active, not recruiting
        • Skåne University Hospital
      • Stockholm, Sweden
        • Active, not recruiting
        • Karolinska University Hospital
      • Umeå, Sweden
        • Recruiting
        • Umea University Hospital
      • Uppsala, Sweden
        • Recruiting
        • Children's UH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Medium Risk (MR)
Subject is defined as MR if > 6months of age at diagnosis, OR < 6 months of age with White Blood cell Count (WBC) < 300 at diagnosis and good prednisone response. Subject gets 1st cycle of blinatumomab. If MRD is >0.01%, after 1st cycle of blinatumomab, subject will be allocated to HR treatment from that phase, and will be eligible for HSCT. If MRD is undetectable or < 0.01% after the 1st cycle of blinatumomab (TP2) patient will be eligible for replacement of MARMA by 2nd cycle of blinatumomab after receipt of lymphoid style consolidation (Protocol IB) or of myeloid style consolidation (ADE/MAE).
Drug: Blinatumomab
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.
Other Names:
  • Cycle 1
Drug: Blinatumomab
2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
Other Names:
  • Cycle 2
Other: High risk (HR)

Subject is defined as HR if < 6 months of age with WBC > 300 at diagnosis OR poor prednisone response. Also MR patients with end of induction MRD ≥ 1%, or MRD > 0.01% after the 1st cycle of blinatumomab, will be allocated to HR treatment. Subject gets 1 cycle of blinatumomab.

Thereafter patient is eligible for hematopoietic stem cell transplantation (HSCT) with or without experimental therapy in an investigational window.
Drug: Blinatumomab
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.
Other Names:
  • Cycle 1
Drug: Blinatumomab
2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
Other Names:
  • Cycle 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free survival (EFS).
Time Frame: 5 years
The primary endpoint is EFS, defined as the time from diagnosis to resistance to induction, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 8 years
The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.
8 years
Endpoints by risk group
Time Frame: 8 years
The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.
8 years
Outcome for the entire study cohort and according to risk group
Time Frame: 8 years
Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated.
8 years
Minimal Residual Disease
Time Frame: 8 years
MRD response as defined in the protocol and frequencies of MRD levels
8 years
CD19 (cluster of differentiation antigen 19) negative relapse
Time Frame: 8 years
Proportion of CD19 negative relapses in the entire study cohort and according to risk group
8 years
Myeloid lineage switches
Time Frame: 8 years
Proportion of myeloid lineage switches in the entire study cohort and according to risk group
8 years
Grade ≥3 adverse event
Time Frame: 8 years
Proportion of grade ≥3 adverse event (AEs) during the blinatumomab course(s). Proportion of adverse events of special interest (AESIs) and serious adverse events (SAEs) in all protocol phases.
8 years
Grade ≥2 cardiac disorders
Time Frame: 5 years
Proportion of grade ≥2 cardiac disorders at 2 and 5 years after diagnosis
5 years
Overall survival after 1st relapse
Time Frame: 8 years
Overall survival (OS) after first relapse, defined as the time from first relapse to death from any cause, in the entire study cohort and according to risk group
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Maxima Center for Pediatric Oncology

Collaborators

University of Milano Bicocca
Amgen Europe B.V

Investigators

  • Principal Investigator: Janine Stutterheim, Dr, Princess Maxima Center for Pediatric Oncology in The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-000213-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all individual participant data that underlie results in a publication

IPD Sharing Time Frame

The Clinical Study Report (CSR) will be made available within 6 months upon study end.

IPD Sharing Access Criteria

A summary of the study results will be made public via www.clinical trials.gov as well as to Ethical committees/ Health Authorities and all participating patients by providing them through their treating physicians a patient letter with a summary of the results.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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