Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Recruiting
Phase 2
Interventional Study
Pediatric Acute Lymphoblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 19
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 370 (estimated)
- Sponsor
- Jae Wook Lee · Other
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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 \< 0.01% after IM #1 :…
Trial Locations
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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,…
Contacts