About this trial
* Clinical and genetic factors consistent with High risk : Induction → Consolidation
1. BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation
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1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification
1. BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
* Difference in the number of \'interim maintenance(IM)\' and \'delayed intensification(DI)\' is important for chemotherapies based on MRD.
Eligibility criteria
Qualifiers
Age: 1year~19years of age at diagnosis
Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10^9/L at diagnosis
If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement
Disqualifiers
Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
Patients with Down syndrome
potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial)
Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment
Trial design
Treatments tested in this trial
- ALL, High risk
Treatment groups
Sponsors and collaborators
Jae Wook Lee
Lead sponsor
Seoul St. Mary's Hospital
Sponsor institution
Samsung Medical Center
Collaborator
Asan Medical Center
Collaborator
Seoul National University Hospital
Collaborator
Severance Hospital
Collaborator
Pusan National University Yangsan Hospital
Collaborator
Korea University Anam Hospital
Collaborator