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
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
Treatments tested in this trial
- 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
Treatment groups
116 Participants
are divided into 4 treatment groupsSponsors and collaborators
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
Source ClinicalTrials.gov