NCT06099366

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Hee Young Ju · Academic / Other
• Sex: All
• Age: 1 Year – 9 Years
• Healthy volunteers: Not accepted

Summary

Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.

Conditions

• Lymphoblastic Leukemia in Children

Interventions

Type	Name	Description
DRUG	induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate	vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
DRUG	Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate	Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate
DRUG	Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate	Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
DRUG	Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate	Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
DRUG	Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate	Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
DRUG	Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate	Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 Dexamethasone 10mg/m2 Intrathecal Methotrexate
DRUG	Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate	Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
DRUG	Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate	Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

Timeline

• Start date: 2024-03-05
• Primary completion: 2033-12-31
• Completion: 2033-12-31
• First posted: 2023-10-25
• Last updated: 2025-06-08

Locations

9 sites across 1 country: South Korea