Health TrialsbyHealthPanel

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

ConditionLymphoblastic Leukemia in Children
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-9
SponsorHee Young Ju

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following

1 year old ≤ Age < 10 years old

white blood cell at initial diagnosis < 5x10^10/L (50,000uL)

No testis involvement

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • 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

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

    Drug

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

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

    Drug

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

  • 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

  • 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

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

    Drug

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

Treatment groups

116 Participants
are divided into 4 treatment groups
Group A: Standard-low (SL)Experimental treatment 5 interventions
Group B: Standard-average (SA)Experimental treatment 5 interventions
Group C: Standard-high 1 (SH1)Experimental treatment 5 interventions
Group D: Standard-high 2 (SH2)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

5-year event free survival rate

Time frame
Up to 5-years

Secondary outcomes

1

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

Time frame
Up to 5-years
2

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.

Time frame
Up to 5-years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hee Young Ju

Lead sponsor

Samsung Medical Center

Sponsor institution

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

Seoul National University Bundang Hospital

Collaborator

Kyungpook National University Chilgok Hospital

Collaborator

Chungnam National University Hospital

Collaborator

Samsung Medical Center

Collaborator

Ajou University School of Medicine

Collaborator

Source ClinicalTrials.gov
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