Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

PHASE2RecruitingINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

October 20, 2024

Primary Completion Date

December 31, 2034

Study Completion Date

December 31, 2034

Conditions
Acute Lymphoblastic Leukemia, Pediatric
Interventions
DRUG

Dasatinib(Sprycel) arm

"▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)~* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3~ 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance~ 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT~* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT~ 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine~ 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab~ * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib."

DRUG

Non-Dasatinib(Sprycel) arm

"▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction~* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3~ 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT~ 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT~* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT~ 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine~ 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab"

Trial Locations (6)

50612

NOT_YET_RECRUITING

Pusan National University Yangsan Hospital, Yangsan

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

06591

RECRUITING

Seoul saint Mary's Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Asan Medical Center

OTHER

collaborator

Samsung Medical Center

OTHER

collaborator

Severance Hospital

OTHER

collaborator

Pusan National University Yangsan Hospital

OTHER

collaborator

Seoul St. Mary's Hospital

OTHER

lead

Hyoung Jin Kang

OTHER

NCT06257394 - Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea | Biotech Hunter | Biotech Hunter