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RecruitingPhase 2NCT06184009

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study

Sponsor

Jae Wook Lee

Enrollment

370 participants

Start Date

Aug 10, 2024

Study Type

INTERVENTIONAL

Conditions

Pediatric Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 1 YearMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment plan for children and young people who have just been diagnosed with a high-risk form of B-cell acute lymphoblastic leukemia (ALL), a type of blood cancer. The goal is to improve survival rates and reduce side effects through an intensive but structured therapy approach. **You may be eligible if...** - You are between 1 and 19 years old at the time of diagnosis - You have been newly diagnosed with Pre-B ALL that is considered high-risk (for example, because of your age, white blood cell count at diagnosis, or certain genetic features of the cancer) - You have not yet started treatment for this leukemia **You may NOT be eligible if...** - You have a different type of leukemia (such as T-cell ALL or Philadelphia chromosome-positive ALL under certain criteria) - You have already received chemotherapy for this condition - You have other serious health conditions that would interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALL, 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

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NCT06184009

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