Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blinatumomab, Blinatumomab.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia. Basic parameters: 1 Day — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina, Australia, Austria, Belgium, Czechia +19
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
Overview
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.
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.
Interventions
- 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. - Drug Blinatumomab
2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
Primary outcome measures
- Event free survival (EFS). [Time frame: 5 years]
Secondary outcome measures (9)
- Overall survival [Time frame: 8 years]
- Endpoints by risk group [Time frame: 8 years]
- Outcome for the entire study cohort and according to risk group [Time frame: 8 years]
- Minimal Residual Disease [Time frame: 8 years]
- CD19 (cluster of differentiation antigen 19) negative relapse [Time frame: 8 years]
- Myeloid lineage switches [Time frame: 8 years]
- Grade ≥3 adverse event [Time frame: 8 years]
- Grade ≥2 cardiac disorders [Time frame: 5 years]
- Overall survival after 1st relapse [Time frame: 8 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria for blinatumomab:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 20 centers
- Universitätsklinikum Augsburg — Augsburg
- Charite Universitaetsmedizin Berlin KöR — Berlin
- Universitaetsklinikum Bonn AöR — Bonn
- Klinikum Dortmund gGmbH — Dortmund
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden Aö — Dresden
- Universitaetsklinikum Erlangen AöR — Erlangen
- Justus-Liebig-Universitaet Giessen — Giessen
- Universitaetsklinikum Halle (Saale) AöR — Halle
- … and 12 more centers
Japan · 20 centers
Center list to be confirmed — check the primary protocol.
France · 18 centers
- CHU Amiens — Amiens
- CHU Besancon — Besançon
- CHU de Bordeaux — Bordeaux
- HCE — Grenoble
- CHRU de Lille — Lille
- Institute of Hematology and Pediatric Oncology — Lyon
- CHU Timone — Marseille
- CHI Montpellier — Montpellier
- … and 10 more centers
Australia · 9 centers
- Australian and New Zealand Children's Haematology/Oncology Group — Clayton
- North Adelaide- Womens and Childrens Hospital — Adelaide
- Monash Children's Hosptial — Clayton
- New Lambton Heights- John Hunter Children's Hospital — New Lambton Heights
- Royal Children's Hospital (Children's Cancer Centre) — Parkville
- Perth Children's Hospital — Perth
- Queensland Children's Hospital — South Brisbane
- Sydney Childrens Hospital — Sydney
- … and 1 more center
Belgium · 7 centers
- Antwerp University Hospital — Antwerp
- Cliniques Universitaires Saint-Luc — Brussels
- Hôpital Universitaire des Enfants Reine Fabiola — Brussels
- Universitair Ziekenhuis Gent — Ghent
- UZ Leuven — Leuven
- Centre Hospitalier Regional De La Citadelle — Liège
- CHC MontLegia — Liège
Italy · 6 centers
- Azienda Ospedaliera Universitaria Meyer IRCCS — Florence
- L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon — Naples
- … and 4 more centers
Sweden · 6 centers
Center list to be confirmed — check the primary protocol.
Finland · 5 centers
- New Children's Hospital — Helsinki
- Kuopio University Hospital — Kuopio
- Oulu University Hospital — Oulu
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
Austria · 4 centers
- Medical University Of Graz — Graz
- Medical University Of Innsbruck — Innsbruck
- Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH — Salzburg
- St. Anna Children's Hospital — Vienna
Greece · 4 centers
- Aghia Sophia' Children's Hospital — Athens
- HeSPHO — Athens
- University General Hospital Of Heraklion — Heraklion
- Mitera — Marousi
Spain · 4 centers
Center list to be confirmed — check the primary protocol.
Czechia · 3 centers
- University Hospital Brno — Brno
- University Hospital Olomouc — Olomouc
- Hospital Motol V Uvalu 841 — Prague
Denmark · 3 centers
- AUH Skejby — Aarhus
- Copenhagen-Rigshospitalet — Copenhagen
- Odense University Hospital — Odense
Hungary · 2 centers
- University Semmelweis — Budapest
- University of Pécs — Pécs
New Zealand · 2 centers
Center list to be confirmed — check the primary protocol.
Norway · 2 centers
Center list to be confirmed — check the primary protocol.
Saudi Arabia · 2 centers
Center list to be confirmed — check the primary protocol.
Argentina · 1 center
- Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan" — Buenos Aires
Ireland · 1 center
- National Children's Cancer Service — Dublin
Israel · 1 center
- Schneider Childrens Medical Center — Petah Tikva
Lithuania · 1 center
Center list to be confirmed — check the primary protocol.
Netherlands · 1 center
Center list to be confirmed — check the primary protocol.
Portugal · 1 center
Center list to be confirmed — check the primary protocol.
Slovakia · 1 center
Center list to be confirmed — check the primary protocol.
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. PMID 41671463
Identifiers
NCT: NCT05327894 · 2021-000213-16