Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study
Overview
- Phase
- Phase 2
- Intervention
- ALL, High risk
- Conditions
- Pediatric Acute Lymphoblastic Leukemia
- Sponsor
- Jae Wook Lee
- Enrollment
- 370
- Locations
- 7
- Primary Endpoint
- Event Free Survival
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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Clinical and genetic factors consistent with High risk : Induction → Consolidation
- BM MRD < 0.01% : IM #1 → DI #1 → IM #2 → Maintenance
- BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after Consolidation
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T cell ALL : Change to very high risk regimen
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Pre-B ALL : IM #1 → Intensification
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BM MRD < 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance
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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
* 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 : 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.
Investigators
Jae Wook Lee
Principal Investigator
Seoul St. Mary's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: ALL, High risk
Outcomes
Primary Outcomes
Event Free Survival
Time Frame: Up to 5 years
Event-free survival rate for 5 years from the date of registration
Secondary Outcomes
- Overall Survival(Up to 5 years)
- Recurred rate(Up to 5 years)
- Death rate related to infusion(Up to 5 years)