150
Participants
Start Date
December 25, 2023
Primary Completion Date
December 25, 2028
Study Completion Date
December 25, 2030
Vincristine
dose 1.5 mg/m2 at days 1, 8, 15 and 22
Dexamethasone
40 mg on days 1-2, 8-9,15-16 and 22-23
Imatinib
600 mg per day from 1 to up to 5 years
Cytarabine
1000 mg/m2/ on days 1, 3 and 5 of consolidation with 2h infusion
Mercaptopurine
50 mg/m2 on days 1 to 28 of maintenance
Methotrexate
1000 mg/m2 on day 1 of consolidation with 24h infusion; and 20 mg/m2 on days 1, 8, 15 and 22 of maintenance
Ponatinib
15 mg per day from consolidation start up to 5 years
allogeneic stem cell transplantation
Allogeneic stem cell transplantation from hematpoietic stem cells progenitors of familiar or not familiar origin. Cord blood transplantation can also be done.
Total body irradiation
Fractionated dose with total dose of 12 Gy between days -4 and -1 of allogeneic stem cell transplantation (alloSCT)
Cyclophosphamide
60 mg/kg on days -6 and -5 before alloSCT
Fludarabine
30 mg/m2 intravenous on days -7, -6, -5 y -4 before alloSCT (alternative to cyclophosphamide)
PETHEMA Foundation
OTHER