Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
NCT ID: NCT06257394
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
74 participants
INTERVENTIONAL
2024-10-20
2034-12-31
Brief Summary
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Detailed Description
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* Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
1. If Minimal Residual Disease \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → DI(Delayed Intensification) #1 → IM(Interim Maintenance) #2 → DI(Delayed Intensification) #2 → Maintenance
2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
1. If Minimal Residual Disease \& qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine
2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab
* In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.
* Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
* Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
1. If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
2. If Minimal Residual Disease positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
1. If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine
2. If Minimal Residual Disease positivie after the post-reinduction : Consolidation #3 using Blinatumomab
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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[Arm A, 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.
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.
[Arm B, 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
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* Philadelphia chromosome-positive t(9;22)(q34;q11) or
* Patients with failed remission who had blast \> 5% on bone marrow test after initial remission induction therapy or
* Hypodiploidy (Number of chromosomes \< 44 (less than 44)) or
* E2A-HLF(Hepatic Leukemia Factor) translocation-positive or
* When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy
Exclusion Criteria
* When the study participant or their legal representative withdraws consent
* Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)
* Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol
1 Year
19 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Samsung Medical Center
OTHER
Severance Hospital
OTHER
Pusan National University Yangsan Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Hyoung Jin Kang
OTHER
Responsible Party
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Hyoung Jin Kang
Professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-2401-028-1500
Identifier Type: -
Identifier Source: org_study_id
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