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Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Sponsor: Jae Wook Lee
Summary
* Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * Difference in the number of \'interim maintenance(IM)\' and \'delayed intensification(DI)\' is important for chemotherapies based on MRD.
Official title: Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study
Key Details
Gender
All
Age Range
1 Year - 19 Years
Study Type
INTERVENTIONAL
Enrollment
370
Start Date
2024-08-10
Completion Date
2030-12-31
Last Updated
2025-06-08
Healthy Volunteers
No
Conditions
Interventions
ALL, High risk
Intervention Description : * Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \< 0.01% after IM #1 : Continue with \'No. 2\' of High risk regimen starting with DI #1 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.
Locations (7)
Seoul National University Hospital
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Seoul saint Mary's Hospital
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea