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RECRUITING
NCT06257394
PHASE2

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

Sponsor: Hyoung Jin Kang

View on ClinicalTrials.gov

Summary

Very high-risk acute lymphoblastic leukemia

Official title: Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Key Details

Gender

All

Age Range

1 Year - 19 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2024-10-20

Completion Date

2034-12-31

Last Updated

2025-06-08

Healthy Volunteers

No

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

Locations (6)

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul saint Mary's Hospital

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea