Status:
RECRUITING
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Lead Sponsor:
Jae Wook Lee
Collaborating Sponsors:
Samsung Medical Center
Asan Medical Center
Conditions:
Pediatric Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-19 years
Phase:
PHASE2
Brief Summary
* 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 ...
Detailed 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 ≥...
Eligibility Criteria
Inclusion
- \<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
Exclusion
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06184009
Start Date
August 10 2024
End Date
December 31 2030
Last Update
June 8 2025
Active Locations (7)
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1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
2
Samsung Medical Center
Seoul, Seoul, South Korea
3
Korea University Anam Hospital
Seoul, South Korea, 02841
4
Severance Hospital
Seoul, South Korea, 03722