Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
- Conditions
- Pediatric Acute Lymphoblastic Leukemia
- Interventions
- Drug: ALL, High risk
- Registration Number
- NCT06184009
- Lead Sponsor
- Jae Wook Lee
- 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 → 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.
- 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
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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
* 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 370
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALL, High risk with DI #2(Doxorubicin) ALL, High risk * 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.
- Primary Outcome Measures
Name Time Method Event Free Survival Up to 5 years Event-free survival rate for 5 years from the date of registration
- Secondary Outcome Measures
Name Time Method Recurred rate Up to 5 years As the period from enrollment to disease progression/recurrence
Death rate related to infusion Up to 5 years The time until defined by date of drug-related mortality from the date of 1st infusion
Overall Survival Up to 5 years The time until defined by date of all-cause mortality from the date of 1st infusion
Trial Locations
- Locations (7)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital🇰🇷Seoul, Korea, Republic ofJun Eun Park, ProfessorContact+82-10-9476-0932pedonco@korea.ac.kr