Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 4, 2024

Primary Completion Date

December 31, 2032

Study Completion Date

December 31, 2032

Conditions
Acute Lymphoid Leukemia
Interventions
DRUG

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

DRUG

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

DRUG

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

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

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"

DRUG

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)

PROCEDURE

Stem Cell Transplantation

All matters related to hematopoietic stem cell transplantation are subject to each institution's practice.

Trial Locations (7)

50612

RECRUITING

Pusan National University Yangsan Hospital, Yangsan

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

06591

RECRUITING

Seoul saint Mary's Hospital, Seoul

All Listed Sponsors
collaborator

Samsung Medical Center

OTHER

collaborator

Seoul National University Hospital

OTHER

collaborator

Severance Hospital

OTHER

collaborator

Chonnam National University Hospital

OTHER

collaborator

Pusan National University Yangsan Hospital

OTHER

collaborator

Seoul St. Mary's Hospital

OTHER

lead

Ho Joon Im

OTHER