Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

Condition(s) studied

Investigational drug(s) / intervention(s)

ALL, High risk: Intervention Description : * Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \&lt; 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \&lt; 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \&lt; 0.01% after IM #1 : Continue with \&#39;No. 2\&#39; of High risk regimen starting with DI #1 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.

Study summary

* Clinical and genetic factors consistent with High risk : Induction → Consolidation

1. BM MRD \&lt; 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 \&lt; 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 \&#39;interim maintenance(IM)\&#39; and \&#39;delayed intensification(DI)\&#39; is important for chemotherapies based on MRD.

Eligibility

Primary outcome measure(s)

• Event Free Survival — Up to 5 years
  Event-free survival rate for 5 years from the date of registration

Trial sites (9)