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

NCT05327894 · tracked via the Priya Life Science Germany tracker

Sponsor

Princess Maxima Center for Pediatric Oncology

Phase

Phase 3

Started

2022-12-15

Last updated

2026-07-10

Condition(s) studied

Acute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemia

Investigational drug(s) / intervention(s)

Blinatumomab →Blinatumomab →

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.

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

Study 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

Sex

ALL

Min age

1 Day

Max age

1 Year

Healthy volunteers

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.

Primary outcome measure(s)

Event free survival (EFS). — 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.

Trial sites (124)

Facility	City	Region	Status
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"	Buenos Aires	Argentina	Suspended
Australian and New Zealand Children's Haematology/Oncology Group	Clayton	Victoria	Recruiting
North Adelaide- Womens and Childrens Hospital	Adelaide	Australia	Recruiting
Monash Children's Hosptial	Clayton	Australia	Active Not Recruiting
New Lambton Heights- John Hunter Children's Hospital	New Lambton Heights	Australia	Recruiting
Royal Children's Hospital (Children's Cancer Centre)	Parkville	Australia	Active Not Recruiting
Perth Children's Hospital	Perth	Australia	Recruiting
Queensland Children's Hospital	South Brisbane	Australia	Active Not Recruiting
Sydney Childrens Hospital	Sydney	Australia	Recruiting
The Childrens Hospital at Westmead	Westmead	Australia	Recruiting
Medical University Of Graz	Graz	Austria	Recruiting
Medical University Of Innsbruck	Innsbruck	Austria	Recruiting
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH	Salzburg	Austria	Recruiting
St. Anna Children's Hospital	Vienna	Austria	Recruiting
Antwerp University Hospital	Antwerp	Belgium	Recruiting
Cliniques Universitaires Saint-Luc	Brussels	Belgium	Active Not Recruiting
Hôpital Universitaire des Enfants Reine Fabiola	Brussels	Belgium	Recruiting
Universitair Ziekenhuis Gent	Ghent	Belgium	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
Centre Hospitalier Regional De La Citadelle	Liège	Belgium	Active Not Recruiting
CHC MontLegia	Liège	Belgium	Recruiting
University Hospital Brno	Brno	Czechia	Recruiting
University Hospital Olomouc	Olomouc	Czechia	Active Not Recruiting
Hospital Motol V Uvalu 841	Prague	Czechia	Recruiting
AUH Skejby	Aarhus	Denmark	Recruiting
Copenhagen-Rigshospitalet	Copenhagen	Denmark	Recruiting
Odense University Hospital	Odense	Denmark	Recruiting
New Children's Hospital	Helsinki	Finland	Recruiting
Kuopio University Hospital	Kuopio	Finland	Recruiting
Oulu University Hospital	Oulu	Finland	Active Not Recruiting
Tampere University Hospital	Tampere	Finland	Recruiting
Turku University Hospital	Turku	Finland	Recruiting
CHU Amiens	Amiens	France	Recruiting
CHU Besancon	Besançon	France	Active Not Recruiting
CHU de Bordeaux	Bordeaux	France	Recruiting
HCE	Grenoble	France	Active Not Recruiting
CHRU de Lille	Lille	France	Active Not Recruiting
Institute of Hematology and Pediatric Oncology	Lyon	France	Recruiting
CHU Timone	Marseille	France	Active Not Recruiting
CHI Montpellier	Montpellier	France	Active Not Recruiting

+ 84 more sites — see the full list on the official registry below.

More Princess Maxima Center for Pediatric Oncology trials in Germany

HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies Recruiting

HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies Recruiting

Vyxeos® With Clofarabine for Pediatric AML Recruiting

HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies Recruiting

Other trials for the same condition

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation Recruiting

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Active, not recruiting

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL Active, not recruiting

HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies Recruiting

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05327894 on ClinicalTrials.gov ↗ ← All trials in Germany