Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-19
SponsorJae Wook Lee

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 \&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 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

370 Participants
are divided into 1 treatment group

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