Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06257394
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Sponsor:
Hyoung Jin Kang
Organization:
Study Overview
Official Title:
Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VHR ALL
Brief Summary:
Very high-risk acute lymphoblastic leukemia
Detailed Description:
* Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
* 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: