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RecruitingPhase 2NCT06257394

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

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

Sponsor

Hyoung Jin Kang

Enrollment

74 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Summary

Very high-risk acute lymphoblastic leukemia

Eligibility

Min Age: 1 YearMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is treating children and teenagers with a very aggressive type of leukemia called very high-risk acute lymphoblastic leukemia (ALL). It focuses on patients whose disease has specific genetic features or has not responded well to initial treatment. **You may be eligible if...** - You are between 1 and 19 years old - You have been diagnosed with ALL and have one or more high-risk features, such as: - A specific chromosome change called Philadelphia chromosome - Cancer cells still present after the first round of treatment - Too few chromosomes in cancer cells (hypodiploidy) - A rare genetic fusion called E2A-HLF - Persistent detectable leukemia cells by sensitive genetic testing (NGS-MRD) **You may NOT be eligible if...** - You have a medical reason that prevents use of the study medications - You or your legal guardian withdraws consent - You are pregnant or breastfeeding - Your doctor determines you are medically unsuitable - You are enrolled in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDasatinib(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.

DRUGNon-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

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NCT06257394

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