Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

NCT06099366 | Recruiting Phase 2

• 1 other identifier: 2023-09-142
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Lymphoblastic Leukemia in Children

Keywords

Standard Risk ALL; NGS MRD

Outcome Measures

Primary Outcomes (1)

• 5-year event free survival rate

  Up to 5-years

Secondary Outcomes (2)

• Confirmation of the therapeutic effect of the initial treatment response

  Up to 5-years

• Disease prognosis-related factor

  Up to 5-years

Study Arms (4)

Standard-low (SL)

EXPERIMENTAL

Induction-\> SL Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion-\> Interim Maintenance 2nd-\> Maintenance

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate; Drug: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate; Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate; Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate; Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Standard-average (SA)

EXPERIMENTAL

Induction-\> SH Consolidation(4weeks)-\> Intensified Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion-\> Interim Maintenance 2nd-\> Maintenance

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate; Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate; Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate; Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate; Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Standard-high 1 (SH1)

EXPERIMENTAL

Induction-\> SL Consolidation(4weeks)-\> Intesified Consolidattion(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion 1st-\> Interim Maintenance 2nd-\> Delayed Intestificaion 2nd-\> Maintenance

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate; Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate; Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate; Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate; Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Standard-high 2 (SH2)

EXPERIMENTAL

Induction-\> SH Consolidation(4weeks)-\> Intensified Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion 1st-\> Interim Maintenance 2nd-\> Delayed Intestificaion 2nd-\> Maintenance

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate; Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate; Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate; Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate; Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Interventions

induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate DRUG

vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate

Standard-average (SA); Standard-high 1 (SH1); Standard-high 2 (SH2); Standard-low (SL)

Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate DRUG

Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate

Standard-low (SL)

Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate DRUG

Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate

Standard-average (SA); Standard-high 1 (SH1); Standard-high 2 (SH2)

Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate DRUG

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

Standard-average (SA); Standard-low (SL)

Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate DRUG

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

Standard-high 1 (SH1); Standard-high 2 (SH2)

Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate DRUG

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

Standard-average (SA); Standard-low (SL)

Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate DRUG

Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

Standard-high 1 (SH1); Standard-high 2 (SH2)

Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate DRUG

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

Standard-average (SA); Standard-high 1 (SH1); Standard-high 2 (SH2); Standard-low (SL)

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
• year old ≤ Age \< 10 years old
• white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
• No testis involvement
• Satisfaction of following organ functions
• A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following:
• to \< 2 years: Male: 0.6 / Female: 0.6, 2 to \< 6 years: Male: 0.8 / Female: 0.8, 6 to \< 10 years: Male: 1 / Female: 1, 10 to \< 13 years: Male: 1.2 / Female: 1.2, 13 to \< 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.
• B. Liver function i. Direct bilirubin \< 3.0mg/dL

You may not qualify if:

• Steroid administration within 2 weeks before the registration
• t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF
• Newly diagnosed T cell ALL
• One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
• Burkitt leukemia/lymphoma
• In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
• When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Sponsors & Collaborators

• Hee Young Ju: lead
• Asan Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Severance Hospital: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Jeju National University Hospital: collaborator

Study Sites (9)

Asan Medical Center

Seoul, Other (Non U.s.), 03174, South Korea

RECRUITING

Samsung Medical Center

Seoul, Other (Non U.s.), 03174, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, Yangsan-si, 50612, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

NOT YET RECRUITING

Jeju National University Hospital

Jeju City, 63241, South Korea

NOT YET RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Seoul saint Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Interventions

Asparaginase; Dexamethasone; Cyclophosphamide; Cytarabine; Methotrexate; Mercaptopurine; Doxorubicin

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfhydryl Compounds; Sulfur Compounds; Purines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Hee Young Ju, MD, Phd

CONTACT

82-2-3410-0865; heeyoung.ju@samsung.com

hyunjung Shin

CONTACT

82-2-3410-6763; hjds.shin@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 25, 2023
• Study Start: March 5, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

KR (9)