90
Participants
Start Date
April 4, 2024
Primary Completion Date
December 31, 2032
Study Completion Date
December 31, 2032
Reinduction(4weeks)
Prednisolone 60 mg/m2/day tid days 1-28, Vincristine 1.5 mg/m2 on days 1, 8, 15, 22, L-asparaginase 6,000 IU/m2(days 2-4 start, total 9 doses for 3 weeks), Idarubicin 10 mg/m2 on days 1, 8, (15\~17), IT Ara-C on days 1, IT MTX on days 8, 29
Cosolodation 1st(3weeks)
Ifosfamide: 1.8 g/m2 (days 1, 2, 3, 4, 5), Etoposide: 100 mg/m2 (days 1, 2, 3, 4, 5), IT MTX on day 1
Consolidation 2nd(3weeks)
MTX: 500 mg/m2 over 30 min followed by 1,000 mg/m2 over 23.5 hr (day 1), Ara-C: 3,000 mg/m2/dose (day 2, 3), IT MTX on day 1
Blinatumomab 1st(High Risk Group)_4 Weeks
Blinatumomab 15 mcg/m²/day(Days: 1-28), Dexamethasone 5 mg/m2/dose on Day 1, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)
Blinatumomab 2nd (High Risk Group)_4 Weeks
Blinatumomab 15 mcg/m²/day(Days: 1-28), IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)
Blinatumomab-Salvage 1st (Very High Risk Group)_4 Weeks
Blinatumomab 9 mcg/day(Weight ≥ 45kg) or 5 mcg/m²/day(Weight \< 45kg) on 1-7 days, 28 mcg/day(Weight ≥ 45kg) or 15 mcg/m²/day(Weight \< 45kg) on 8-28 days, Dexamethasone 5 mg/m2/dose on day 1 and day 8, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)
Blinatumomab-Salvage 2nd (Very High Risk Group)_4 Weeks
Blinatumomab 28 mcg/day(Weight ≥ 45kg) or 15 mcg/m²/day(Weight \< 45kg) on 1-28 days, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)
Intensification course
"\<Intensification 1st(3 Weeks)\> Etoposide: 100 mg/m2 on day 1, 2, 3, Ifosfamide 3.4 g/m2 on day 1, 2, 3~\<Intensification 2nd(2 Weeks)\> Oral 6-mercaptopurine 50 mg/m2/day PO (days 1-14), Methotrexate: 25 mg/m2 on day 1, 8, TIT on day 1~\<Intensification 3rd(3 Weeks)\> Ara-C 1.0 g/m2 (days 1-3), Idarubicin: 5mg/m2 (days 1- 3)~\<Intensification 4th(2 Weeks)\> Dexamethasone 8 mg/m2/day on days 1-14, Vincristine 2 mg/m2 on days 1 and 8, L-asparaginase 10,000 IU/m2 on days 1 and 8"
Maintenance(12 Weeks/Cycle)
Prednisolone: 15 mg/m²/dose(Days 1-5, 29-33, 57-61), Vincristine: 1.5 mg/m²/dose(Day 1, 29, 57), Oral 6-mercaptopurine: 50 mg/m²/dose (Days 1-84), Methotrexate: 20 mg/m²/dose (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78), Intrathecal methotrexate (Day 1)
Stem Cell Transplantation
All matters related to hematopoietic stem cell transplantation are subject to each institution's practice.
RECRUITING
Pusan National University Yangsan Hospital, Yangsan
RECRUITING
Chonnam National University Hwasun Hospital, Hwasun
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Severance Hospital, Seoul
RECRUITING
Asan Medical Center, Seoul
RECRUITING
Samsung Medical Center, Seoul
RECRUITING
Seoul saint Mary's Hospital, Seoul
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Severance Hospital
OTHER
Chonnam National University Hospital
OTHER
Pusan National University Yangsan Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Ho Joon Im
OTHER