| Titre |
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome |
| Protocole ID |
COG-AAML1531 |
| ClinicalTrials.gov ID |
NCT02521493 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
Phase III |
| Type étude |
Traitement |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 CHUL ET CENTRE MERE-ENFANT SOLEIL
2705 boulevard Laurier, Québec, QC, G1V 4G2
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Bruno Michon
|
| Coordonnateur(trice) |
Marie-Christine Gagnon
418-525-4444 poste 40196
|
| Statut |
![]() Fermé |
| 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
|
Groupe d'étude en oncologie du Québec