Titre Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
Protocole ID COG-AAML1531
ClinicalTrials.gov ID NCT02521493
Site Anatomique Pédiatrique divers
Phase Phase III
Type étude Traitement
Ville Montréal
Investigateur principal Dr Yvan Samson
Coordonnateur Frédéric Ancot
Statut Actif en recrutement
Date d'activation
Critètes d'éligibilité
  • Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])
  • Patients with previously untreated de novo AML who meet the criteria for AML with >= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification
  • Patients with cytopenias and/or bone marrow blasts who do not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts are eligible if they meet the criteria for a diagnosis of myelodysplastic syndrome (MDS)
  • Patients with a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention), who:
  • Are > 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR
  • Patients sho have an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart
  • Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD
  • There are no minimal organ function requirements for enrollment on this study
  • Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
  • Each patient's parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met
Critètes d'exclusion
  • Patients with promyelocytic leukemia (French-American-British [FAB] M3)
  • Prior therapy
  • Patients =< 30 days from the last dose of cytarabine used for treatment of TMD