265
Participants
Start Date
April 30, 2016
Primary Completion Date
December 31, 2020
Study Completion Date
December 31, 2025
Nilotinib
400 mg/12h per os D1 to D28 cycles 1-4 300 mg/12h per os D1-D14 interphase
Methotrexate
1 g/m2 continuous Intravenous Infusion (CIV) D1 cycles 2 and 4 25 mg/m2 per os D1, D8 interphase
Aracytine (Ara C)
Age\<45 years: 3 mg/m2/12h D2, D3 cycles 2 and 4 Age\>=45 years: 1.5 mg/m2/12h D2, D3 cycles 2 and 4
Granulocyte Colony-Stimulating Factor (G-CSF)
5µg/kg/d (SC) D6 until neutrophils \> 1 G/L D15 cycles 1 and 3; D6 cycles 2 and 4
Depomedrol
40 mg + methotrexate 15 mg + Aracytine (AraC) 40mg IT cycle 1: D1, D8, D15 IT cycles 2 and 4: D9 IT cycle 3: D1
Dexamethasone
40 mg per os, D1-D2, D8-D9, D15-D16, D22-D23, cycles 1 and 3
Vincristine
2 mg total dose IV, D1 D8 D15 D22 cycles 1 and 3
Imatinib
300 mg/12h per os in post-SCT maintenance therapy for during at least 2 years
6 Mercaptopurine (6MP)
60 mg/m2 per os, D1 to D14, interphase
RECRUITING
Hopital Saint Louis, Paris
Assistance Publique - Hôpitaux de Paris
OTHER