Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Interfant-21
Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
1 other identifier
interventional
160
23 countries
111
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2022
Longer than P75 for phase_3
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
April 13, 2026
April 1, 2026
4.7 years
April 7, 2022
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event free survival (EFS).
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 Outcomes (9)
Overall survival
8 years
Endpoints by risk group
8 years
Outcome for the entire study cohort and according to risk group
8 years
Minimal Residual Disease
8 years
CD19 (cluster of differentiation antigen 19) negative relapse
8 years
- +4 more secondary outcomes
Study Arms (2)
Medium Risk (MR)
OTHERSubject 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).
High risk (HR)
OTHERSubject 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- ≤ 365 days of age at the time of diagnosis of ALL.
- Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.
You may not qualify if:
- KMT2A-wildtype patients.
- Multilineage MPAL
- T-ALL.
- Age \> 365 days at the time of diagnosis.
- Down syndrome.
- Relapsed ALL.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Princess Maxima Center for Pediatric Oncologylead
- University of Milano Bicoccacollaborator
- Amgen Europe B.Vcollaborator
Study Sites (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, 3584 CS, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janine Stutterheim, Dr
Princess Maxima Center for Pediatric Oncology in The Netherlands
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2022
First Posted
April 14, 2022
Study Start
December 15, 2022
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- The Clinical Study Report (CSR) will be made available within 6 months upon study end.
- 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.
all individual participant data that underlie results in a publication