Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

August 10, 2024

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Pediatric Acute Lymphoblastic Leukemia
Interventions
DRUG

ALL, High risk

"Intervention Description :~* Clinical and genetic factors consistent with High risk : Induction → Consolidation~ 1. BM MRD \&lt; 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance~ 2. BM MRD ≥ 0.01% after Induction, \&lt; 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 \&lt; 0.01% after IM #1 : Continue with \&#39;No. 2\&#39; 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."

Trial Locations (7)

50612

RECRUITING

Pusan National University Yangsan Hospital, Yangsan

03080

RECRUITING

Seoul National University Hospital, Seoul

Unknown

RECRUITING

Samsung Medical Center, Seoul

02841

NOT_YET_RECRUITING

Korea University Anam Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06591

RECRUITING

Seoul saint Mary's Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Samsung Medical Center

OTHER

collaborator

Asan Medical Center

OTHER

collaborator

Seoul National University Hospital

OTHER

collaborator

Severance Hospital

OTHER

collaborator

Pusan National University Yangsan Hospital

OTHER

collaborator

Korea University Anam Hospital

OTHER

lead

Jae Wook Lee

OTHER

NCT06184009 - Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter