Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.
Eligibility
Primary outcome measure(s)
- Safety/Efficacy — through study completion, an average of 9 year
Patients with relapsed acute lymphoblastic leukemia are being treated after sorted into groups with their potential risk, and disease-free survival rate will be checked.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Kyungpook National University Chilgok Hospital | Daegu | South Korea | Not Yet Recruiting |
| Chungnam National University Hospital | Daejeon | South Korea | Not Yet Recruiting |
| Chonnam National University Hwasun Hospital | Hwasun | South Korea | Recruiting |
| Jeju National University Hospital | Jeju City | South Korea | Not Yet Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Severance Hospital | Seoul | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Seoul saint Mary's Hospital | Seoul | South Korea | Recruiting |
| Pusan National University Yangsan Hospital | Yangsan | South Korea | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05827549 on ClinicalTrials.gov ↗ ← All trials in South Korea