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Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

NCT06184009 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2025-06-08

No results posted yet for this study

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

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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.

Conditions

  • Pediatric Acute Lymphoblastic Leukemia

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.

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Pusan National University Yangsan Hospital

    collaborator OTHER

  • Korea University Anam Hospital

    collaborator OTHER

  • Jae Wook Lee

    lead OTHER

Principal Investigators

  • Jae Wook Lee, Ph.D · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-10
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06184009 on ClinicalTrials.gov