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Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

RecruitingPhase 2Ages 1 Year - 19 YearsAllJae Wook Lee
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In plain words

What the trial is, and whether it could suit you

* Clinical and genetic factors consistent with High risk : Induction โ†’ Consolidation 1. BM MRD \&lt; 0.01% : IM #1 โ†’ DI #1 โ†’ IM #2 โ†’ Maintenance 2. BM MRD โ‰ฅ 0.01% : IM #1 โ†’ DI #1 โ†’ IM #2 โ†’ DI #2 โ†’ Maintenance 3. BM MRD โ‰ฅ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 โ†’ Intensification 1. BM MRD \&lt; 0.01% after IM #1 : DI #1 โ†’ IM #2 โ†’ DI #2 โ†’ Maintenance 2. BM MRD โ‰ฅ 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
\<Inclusion Criteria\> * 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 * High-risk gene variants: KMT2A rearrangement intrachromosomal amplification of chromosome 21 (iAMP21) โ— If subjects are under the age of 10 at the time of diagnosis and took steroids for more than 24 hours within two weeks before the diagnosis, the risk group will be determined by the presence of a whole blood test within three days before starting steroids. If a whole blood test is performed within three days before beginning steroids, the risk group will be assessed based on the white blood cell count in the test. If there is no whole blood test before starting steroids, subjects are classified as a high-risk group. If subjects are ten or older at diagnosis, pre-diagnosis steroid treatment will not affect the risk classification. * Newly diagnosed T cell ALL \<Exclusion Criteria\> * 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 * Participating in an interventional clinical trial other than this research
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What it tests

  • ALL, High risk
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Where

9 sites
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Inha University Hospital
Incheon, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Seoul saint Mary's Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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