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RECRUITING
NCT06184009
PHASE2

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

Sponsor: Jae Wook Lee

View on ClinicalTrials.gov

Summary

* Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \&lt; 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 \&lt; 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 \&#39;interim maintenance(IM)\&#39; and \&#39;delayed intensification(DI)\&#39; 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

Interventions

DRUG

ALL, High risk

Intervention Description : * Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \&lt; 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \&lt; 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 \&lt; 0.01% after IM #1 : Continue with \&#39;No. 2\&#39; 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