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Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Primary Purpose

Lymphoblastic Leukemia in Children

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Sponsored by
Hee Young Ju
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoblastic Leukemia in Children

Eligibility Criteria

1 Year - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-5 of following 1 year old ≤ Age < 10 years old white blood cell at initial diagnosis < 5x10^10/L (50,000uL) CNS 1 or 2 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: 1 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 B. Liver function i. Direct bilirubin < 3.0mg/dL C. Cardiac function i. Shortening fraction ≥ 27% confirmed by cardiac echography ii. Ejection fraction ≥ 50% confirmed by cardiac echography Exclusion Criteria: Steroid administration within 2 weeks before the diagnosis t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF 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 When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Standard-low (SL)

    Standard-average (SA)

    Standard-high 1 (SH1)

    Standard-high 2 (SH2)

    Arm Description

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

    Induction-> SH Consolidation(8weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

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

    Induction-> SH Consolidattion(8weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance

    Outcomes

    Primary Outcome Measures

    5-year event free survival rate

    Secondary Outcome Measures

    Confirmation of the therapeutic effect of the initial treatment response
    Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment
    Disease prognosis-related factor
    Relapse-free survival according to presence or absence of known good prognosis factors(high hyperdilpoidy, ETV6/RUNX1, Trisomy 4/10/17) have no clinical significance when NGS MRD based stratified treatment is performed.

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 24, 2023
    Sponsor
    Hee Young Ju
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099366
    Brief Title
    Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
    Official Title
    Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2033 (Anticipated)
    Study Completion Date
    December 31, 2033 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hee Young Ju

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for standard risk acute lymphoblastic leukemia in children and adolescents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoblastic Leukemia in Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    116 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard-low (SL)
    Arm Type
    Experimental
    Arm Description
    Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
    Arm Title
    Standard-average (SA)
    Arm Type
    Experimental
    Arm Description
    Induction-> SH Consolidation(8weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
    Arm Title
    Standard-high 1 (SH1)
    Arm Type
    Experimental
    Arm Description
    Induction-> SL Consolidation(4weeks)-> SH Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
    Arm Title
    Standard-high 2 (SH2)
    Arm Type
    Experimental
    Arm Description
    Induction-> SH Consolidattion(8weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
    Intervention Type
    Drug
    Intervention Name(s)
    induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
    Intervention Description
    vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
    Intervention Type
    Drug
    Intervention Name(s)
    Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
    Intervention Description
    Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate
    Intervention Type
    Drug
    Intervention Name(s)
    Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
    Intervention Description
    Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
    Intervention Type
    Drug
    Intervention Name(s)
    Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
    Intervention Description
    Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
    Intervention Type
    Drug
    Intervention Name(s)
    Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
    Intervention Description
    Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
    Intervention Type
    Drug
    Intervention Name(s)
    Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
    Intervention Description
    Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
    Intervention Type
    Drug
    Intervention Name(s)
    Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
    Intervention Description
    Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
    Primary Outcome Measure Information:
    Title
    5-year event free survival rate
    Time Frame
    Up to 5-years
    Secondary Outcome Measure Information:
    Title
    Confirmation of the therapeutic effect of the initial treatment response
    Description
    Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment
    Time Frame
    Up to 5-years
    Title
    Disease prognosis-related factor
    Description
    Relapse-free survival according to presence or absence of known good prognosis factors(high hyperdilpoidy, ETV6/RUNX1, Trisomy 4/10/17) have no clinical significance when NGS MRD based stratified treatment is performed.
    Time Frame
    Up to 5-years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-5 of following 1 year old ≤ Age < 10 years old white blood cell at initial diagnosis < 5x10^10/L (50,000uL) CNS 1 or 2 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: 1 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 B. Liver function i. Direct bilirubin < 3.0mg/dL C. Cardiac function i. Shortening fraction ≥ 27% confirmed by cardiac echography ii. Ejection fraction ≥ 50% confirmed by cardiac echography Exclusion Criteria: Steroid administration within 2 weeks before the diagnosis t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF 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 When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hee Young Ju, MD, Phd
    Phone
    82-2-3410-0865
    Email
    heeyoung.ju@samsung.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    hyunjung Shin
    Phone
    82-2-3410-6763
    Email
    hjds.shin@samsung.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

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