Informations générales (source: ClinicalTrials.gov)
Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
Interventional
Phase 3
Princess Maxima Center for Pediatric Oncology (Voir sur ClinicalTrials)
décembre 2022
septembre 2030
03 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:40:28 | Contacter | |||
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | |||||
| AP-HP - Hôpital Robert Debré | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Besancon - Besancon - France | Contact (sur clinicalTrials) | ||||
| CHU Charles Nicolle - Rouen - France | Contact (sur clinicalTrials) | ||||
| Hôpital Robert Debré, APHP - Paris - France | Contact (sur clinicalTrials) | ||||
| Institute of Hematology and Pediatric Oncology - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.