Acute Lymphoblastic LeukemiaPhase 3Interfant-21NCT05327894
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
A Phase 3 study testing Blinatumomab in people with Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, run by Princess Maxima Center for Pediatric Oncology at 124 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 124 sitesin 24 countries
- Study dates
- 15 Dec 2022to Sep 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
Trial locations and contacts
124 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
124 sites in 24 countries
Germany20 sites, 17 recruiting
- Recruiting
Universitätsklinikum Augsburg
Augsburg
- Recruiting
Charite Universitaetsmedizin Berlin KöR
Berlin
- Recruiting
Universitaetsklinikum Bonn AöR
Bonn
- Recruiting
Klinikum Dortmund gGmbH
Dortmund
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden
- Recruiting
Universitaetsklinikum Erlangen AöR
Erlangen
- Recruiting
Justus-Liebig-Universitaet Giessen
Giessen
- Recruiting
Universitaetsklinikum Halle (Saale) AöR
Halle
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
- Active, not recruiting
Universtitätsklinikum Eppendorf
Hamburg
- Recruiting
Medizinische Hochschule Hannover
Hanover
- Recruiting
Universitätsklinikum Heidelberg AöR
Heidelberg
- Recruiting
Universitaetsklinikum Schleswig-Holstein AöR
Kiel
- Active, not recruiting
HELIOS Klinikum Krefeld GmbH
Krefeld
- Recruiting
Johannes Gutenberg University Mainz
Mainz
- Recruiting
Klinikum rechts der Isar der TU Muenchen AöR
München
- Active, not recruiting
Universitaetsklinikum Muenster AöR
Münster
- Recruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart
- Recruiting
Universitaetsklinikum Tuebingen AöR
Tübingen
- Recruiting
Universitätsklinikum Ulm
Ulm
Japan20 sites, 18 recruiting
- Recruiting
Chiba University Hospital
Chiba
- Recruiting
Ehime University Hospital
Ehime
- Recruiting
Hiroshima University Hospital
Hiroshima
- Recruiting
Hokkaido University Hospital
Hokkaido
- Recruiting
Hyogo Prefectural Kobe Childrens Hospital
Hyōgo
- Recruiting
Kagoshima University Hospital
Kagoshima
- Recruiting
Kanagawa Childrens Medical Center
Kanagawa
- Recruiting
Kyoto Prefectural University of Medicine
Kyoto
- Recruiting
Kyoto University Hospital
Kyoto
- Active, not recruiting
Mie University Hospital
Mie
- Recruiting
Nagoya University Graduate School of Medicine
Nagoya
- Recruiting
Osaka City General Hospital
Osaka
- Recruiting
Osaka University Graduate School of Medicine 2-2
Osaka
- Recruiting
Saitama Prefectural Childrens Medical Center
Saitama
- Recruiting
Shizuoka Childrens Hospital
Shizuoka
- Recruiting
Tohoku University Hospital
Tōhoku
- Recruiting
National Center for Child Health and Development
Tokyo
- Recruiting
Nippon Medical School Hospital
Tokyo
- Recruiting
The University of Tokyo Hospital
Tokyo
- Active, not recruiting
Tokyo Metropolitan Childre's Medical Center
Tokyo
France18 sites, 14 recruiting
- Recruiting
CHU Amiens
Amiens
- Recruiting
CHU Besancon
Besançon
- Recruiting
CHU de Bordeaux
Bordeaux
- Active, not recruiting
HCE
Grenoble
- Recruiting
CHRU de Lille
Lille
- Recruiting
Institute of Hematology and Pediatric Oncology
Lyon
- Active, not recruiting
CHU Timone
Marseille
- Active, not recruiting
CHI Montpellier
Montpellier
- Recruiting
CHU Nancy
Nancy
- Recruiting
CHU Nantes
Nantes
- Active, not recruiting
CHU de Nice
Nice
- Recruiting
Hôpital Robert Debré, APHP
Paris
- Recruiting
TRS
Paris
- Recruiting
CHU Reims
Reims
- Recruiting
CHU Rennes
Rennes
- Recruiting
CHU Charles Nicolle
Rouen
- Recruiting
CHRU Strasbourg Hautepierre
Strasbourg
- Recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse
Australia9 sites, 6 recruiting
- Recruiting
North Adelaide- Womens and Childrens Hospital
Adelaide
- Recruiting
Australian and New Zealand Children's Haematology/Oncology Group
Clayton, Victoria
- Active, not recruiting
Monash Children's Hosptial
Clayton
- Recruiting
New Lambton Heights- John Hunter Children's Hospital
New Lambton Heights
- Active, not recruiting
Royal Children's Hospital (Children's Cancer Centre)
Parkville
- Recruiting
Perth Children's Hospital
Perth
- Active, not recruiting
Queensland Children's Hospital
South Brisbane
- Recruiting
Sydney Childrens Hospital
Sydney
- Recruiting
The Childrens Hospital at Westmead
Westmead
Belgium7 sites, 6 recruiting
- Recruiting
Antwerp University Hospital
Antwerp
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels
- Recruiting
Hôpital Universitaire des Enfants Reine Fabiola
Brussels
- Recruiting
Universitair Ziekenhuis Gent
Ghent
- Recruiting
UZ Leuven
Leuven
- Active, not recruiting
Centre Hospitalier Regional De La Citadelle
Liège
- Recruiting
CHC MontLegia
Liège
Italy6 sites, 6 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence
- Recruiting
L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
Naples
- Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù
Roma
- Recruiting
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Torino
- Recruiting
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Trieste
- Recruiting
University Of Verona Medical School
Verona
Sweden6 sites, 4 recruiting
- Recruiting
Childrens Cancer Center Queen Silvia Children´s Hospital, Sahlgrenska University Hospital
Gothenburg
- Recruiting
Linkoping University Hospital
Linköping
- Active, not recruiting
Skane University Hospital
Lund
- Active, not recruiting
Karolinska University Hospital
Stockholm
- Recruiting
Umea University Hospital
Umeå
- Recruiting
Children's UH
Uppsala
Finland5 sites, 4 recruiting
- Recruiting
New Children's Hospital
Helsinki
- Recruiting
Kuopio University Hospital
Kuopio
- Active, not recruiting
Oulu University Hospital
Oulu
- Recruiting
Tampere University Hospital
Tampere
- Recruiting
Turku University Hospital
Turku
Austria4 sites, 4 recruiting
- Recruiting
Medical University Of Graz
Graz
- Recruiting
Medical University Of Innsbruck
Innsbruck
- Recruiting
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Salzburg
- Recruiting
St. Anna Children's Hospital
Vienna
Greece4 sites, 1 recruiting
- Active, not recruiting
Aghia Sophia' Children's Hospital
Athens
- Active, not recruiting
HeSPHO
Athens
- Recruiting
University General Hospital Of Heraklion
Heraklion
- Active, not recruiting
Mitera
Marousi
Spain4 sites, 4 recruiting
- Recruiting
Vall D'hebron Institut De Recerca
Barcelona
- Recruiting
Hospital Infantil Universitario Nino Jesus
Madrid
- Recruiting
University Hospital Virgen Del Rocio S.L.
Seville
- Recruiting
Hospital Universitario Y Politecnico La Fe
Valencia
Czechia3 sites, 2 recruiting
- Recruiting
University Hospital Brno
Brno
- Active, not recruiting
University Hospital Olomouc
Olomouc
- Recruiting
Hospital Motol V Uvalu 841
Prague
Denmark3 sites, 3 recruiting
- Recruiting
AUH Skejby
Aarhus
- Recruiting
Copenhagen-Rigshospitalet
Copenhagen
- Recruiting
Odense University Hospital
Odense
Hungary2 sites, 2 recruiting
- Recruiting
University Semmelweis
Budapest
- Recruiting
University of Pécs
Pécs
New Zealand2 sites, 2 recruiting
- Recruiting
Starship Children's Hospital
Auckland
- Recruiting
Christchurch Children's Hospital
Christchurch
Norway2 sites, 2 recruiting
- Recruiting
Haukeland University Hospital
Bergen
- Recruiting
St. Olavs Hospital
Trondheim
Saudi Arabia2 sites, 1 recruiting
- Active, not recruiting
Jeddah-King Abdulaziz Medical City
Jeddah
- Recruiting
King Abdulaziz Medical City, King Abdullah International Medical Research Center
Riyadh
Argentina1 site
- Suspended
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"
Buenos Aires
Ireland1 site, 1 recruiting
- Recruiting
National Children's Cancer Service
Dublin
Israel1 site, 1 recruiting
- Recruiting
Schneider Childrens Medical Center
Petah Tikva
Lithuania1 site
- Active, not recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Netherlands1 site, 1 recruiting
- Recruiting
Princess Máxima Center for pediatric oncology
Utrecht, Utrecht, 3584 CS
trialmanagement@prinsesmaximacentrum.nl
Portugal1 site, 1 recruiting
- Recruiting
Instituto Portugues de Oncologica Lisboa
Lisbon
Slovakia1 site, 1 recruiting
- Recruiting
National Institute of Children's Diseases
Bratislava
About this study
Official title: 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.
Read the 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.
- Being tested
- Blinatumomab
- Keywords
- infant under one year, KMT2A-wildtype
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called Cycle 1
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.
BlinatumomabDrug
Also called Cycle 2
2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
| Study group | Role | What they receive |
|---|---|---|
| Medium Risk (MR) | Other | 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). Receives: Drug: Blinatumomab |
| High risk (HR) | Other | 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. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (9)
Overall survival
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.
Measured: 8 years
Endpoints by risk group
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.
Measured: 8 years
Outcome for the entire study cohort and according to risk group
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.
Measured: 8 years
Minimal Residual Disease
MRD response as defined in the protocol and frequencies of MRD levels
Measured: 8 years
CD19 (cluster of differentiation antigen 19) negative relapse
Proportion of CD19 negative relapses in the entire study cohort and according to risk group
Measured: 8 years
Myeloid lineage switches
Proportion of myeloid lineage switches in the entire study cohort and according to risk group
Measured: 8 years
Grade ≥3 adverse event
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.
Measured: 8 years
Grade ≥2 cardiac disorders
Proportion of grade ≥2 cardiac disorders at 2 and 5 years after diagnosis
Measured: 5 years
Overall survival after 1st relapse
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
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 Dec 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca, Amgen Europe B.V
- Responsible party
- Sponsor
- Investigators
- Janine Stutterheim, Dr, Principal investigator, Princess Maxima Center for Pediatric Oncology in The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327894
- Sponsor's protocol ID
- 2021-000213-16
- Acronym
- Interfant-21
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie results in a publication
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463