RecruitingPhase 2NCT06099366

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in


Sponsor

Hee Young Ju

Enrollment

116 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 9 Years

Plain Language Summary

Simplified for easier understanding

This study is treating children and teenagers with newly diagnosed standard-risk acute lymphoblastic leukemia (ALL), which is a cancer of the blood and bone marrow. It follows a treatment protocol designed specifically for lower-risk pediatric patients whose cancer is not showing the most dangerous features. **You may be eligible if...** - Your child is between 1 and 10 years old - Your child has been newly diagnosed with ALL (standard risk as defined by the study) - White blood cell count at diagnosis was below 50,000/uL - There is no cancer spread to the testicles - Kidney and liver function are adequate - The cancer does not have certain high-risk genetic features (such as the Philadelphia chromosome or specific other rearrangements) **You may NOT be eligible if...** - Steroids were given within the past 2 weeks before registration - The ALL has high-risk genetic features (Philadelphia chromosome, certain translocations, or complex chromosomal changes) - The ALL is T-cell type - Your child has Down syndrome, Fanconi anemia, Bloom syndrome, or other inherited bone marrow failure conditions - The leukemia is Burkitt type - Your child has significant heart problems on an ECG 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

DRUGinduction: 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

DRUGConsolidation: 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

DRUGConsolidation: 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

DRUGInterim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate

Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate

DRUGInterim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate

Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate

DRUGDelayed 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

DRUGDelayed 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

DRUGMaintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate


Locations(9)

Asan Medical Center

Seoul, Other (Non U.s.), South Korea

Samsung Medical Center

Seoul, Other (Non U.s.), South Korea

Pusan National University Yangsan Hospital

Yangsan, Yangsan-si, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Jeju National University Hospital

Jeju City, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Seoul saint Mary's Hospital

Seoul, South Korea

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NCT06099366


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