NCT05827549

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ho Joon Im · Academic / Other
• Sex: All
• Age: 1 Year – 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Risk Assessment is classified as follows based on the NGS-MRD results evaluated after EOI(End of Induction). \<Standard Risk\> * Late (Relapse ≥ 1 year after off treatment) B-ALL marrow or Combined relapse AND * End of induction MRD \< 0.01% \<High Risk\> * T-ALL marrow or combined relapse (any timing) * All other B-ALL marrow or combined relapse cases \<Very High Risk\> • End of Induction BM ≥ M2 AND B -ALL marrow or combined relapse

Conditions

• Acute Lymphoid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-04
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2023-04-25
• Last updated: 2025-06-06

Locations

7 sites across 1 country: South Korea