Clinical Trials in Sweden / NCT05327894
Recruiting
Phase 3
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 Sweden tracker
Condition(s) studied
Acute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemia
Investigational drug(s) / intervention(s)
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
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 Sweden
International Leukemia Target Board
Recruiting
Other trials for the same condition
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 Sweden