Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
NCT ID: NCT06184009
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
370 participants
INTERVENTIONAL
2024-08-10
2030-12-31
Brief Summary
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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.
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Detailed Description
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1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
2. BM MRD ≥ 0.01% after Induction, \< 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 \< 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ALL, High risk with DI #2(Doxorubicin)
* Clinical and genetic factors consistent with High risk : Induction → Consolidation
1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
2. BM MRD ≥ 0.01% after Induction, \< 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 \< 0.01% after IM #1 : Continue with \'No. 2\' 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.
ALL, High risk
Intervention Description :
* Clinical and genetic factors consistent with High risk : Induction → Consolidation
1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
2. BM MRD ≥ 0.01% after Induction, \< 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 \< 0.01% after IM #1 : Continue with \'No. 2\' 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.
Interventions
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ALL, High risk
Intervention Description :
* Clinical and genetic factors consistent with High risk : Induction → Consolidation
1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
2. BM MRD ≥ 0.01% after Induction, \< 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 \< 0.01% after IM #1 : Continue with \'No. 2\' 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
1 Year
19 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Asan Medical Center
OTHER
Seoul National University Hospital
OTHER
Severance Hospital
OTHER
Pusan National University Yangsan Hospital
OTHER
Korea University Anam Hospital
OTHER
Jae Wook Lee
OTHER
Responsible Party
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Jae Wook Lee
Principal Investigator
Principal Investigators
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Jae Wook Lee, Ph.D
Role: STUDY_CHAIR
The Catholic University of Korea
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, 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
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-3626-0001
Identifier Type: -
Identifier Source: org_study_id
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