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Recruiting NCT06184009

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

Phase II Interventional Pediatric Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALL, High risk.
Who it may be relevant to
Registry conditions: Pediatric Acute Lymphoblastic Leukemia. Basic parameters: 1 year — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study

Overview

* 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 <!-- --> 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.

Detailed 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

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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

* 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.

Interventions

  • Drug 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; 0.0

Primary outcome measures

  • Event Free Survival [Time frame: Up to 5 years]
Secondary outcome measures (3)
  • Overall Survival [Time frame: Up to 5 years]
  • Recurred rate [Time frame: Up to 5 years]
  • Death rate related to infusion [Time frame: Up to 5 years]

Eligibility criteria

<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)

● 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 9 centers
  • Seoul National University Hospital — Seoul
  • Samsung Medical Center — Seoul
  • Inha University Hospital — Incheon
  • Korea University Anam Hospital — Seoul
  • Severance Hospital — Seoul
  • Asan Medical Center — Seoul
  • Seoul saint Mary's Hospital — Seoul
  • Ajou University Hospital — Suwon
  • … and 1 more center

Identifiers

NCT: NCT06184009 · 2023-3626-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗