• GEOQ
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
Stade
Type étude Traitement
Médicament
Institution CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
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