Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184009
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-12-05
Brief Title:
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Sponsor:
Jae Wook Lee
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective Nationwide Multi-center Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
KPHOG202302
Brief Summary:
Clinical and genetic factors consistent with High risk Induction Consolidation
1 BM MRD lt 001 IM 1 DI 1 IM 2 Maintenance
2 BM MRD 001 IM 1 DI 1 IM 2 DI 2 Maintenance
3 BM MRD 001 after Consolidation
-- --
1 T cell ALL Change to very high risk regimen
2 Pre-B ALL IM 1 Intensification
1 BM MRD lt 001 after IM 1 DI 1 IM 2 DI 2 Maintenance
2 BM MRD 001 after IM 1 Change to Very high risk regimen
Difference in the number of 39interim maintenanceIM39 and 39delayed intensificationDI39 is important for chemotherapies based on MRD
1 BM MRD lt 001 IM 1 DI 1 IM 2 Maintenance
2 BM MRD 001 IM 1 DI 1 IM 2 DI 2 Maintenance
3 BM MRD 001 after Consolidation
-- --
1 T cell ALL Change to very high risk regimen
2 Pre-B ALL IM 1 Intensification
1 BM MRD lt 001 after IM 1 DI 1 IM 2 DI 2 Maintenance
2 BM MRD 001 after IM 1 Change to Very high risk regimen
Difference in the number of 39interim maintenanceIM39 and 39delayed intensificationDI39 is important for chemotherapies based on MRD
Detailed Description:
Clinical and genetic factors consistent with High risk Induction Consolidation
1 BM MRD lt 001 after both Induction and Consolidation IM 1 DI 1 IM 2 Maintenance
2 BM MRD 001 after Induction lt 001 after Consolidation IM 1 DI 1 IM 2 DI 2 Maintenance
3 BM MRD 001 after Consolidation
-- --
1 T cell ALL Change to very high risk regimen
2 Pre-B ALL IM 1 Intensification
1 BM MRD lt 001 after IM 1 DI 1 IM 2 DI 2 Maintenance
2 BM MRD 001 after IM 1 Change to Very high risk regimen
T cell ALL patients with M1 BM post-Consolidation will start IM 1 However the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD 001 has been reported
1 BM MRD lt 001 after both Induction and Consolidation IM 1 DI 1 IM 2 Maintenance
2 BM MRD 001 after Induction lt 001 after Consolidation IM 1 DI 1 IM 2 DI 2 Maintenance
3 BM MRD 001 after Consolidation
-- --
1 T cell ALL Change to very high risk regimen
2 Pre-B ALL IM 1 Intensification
1 BM MRD lt 001 after IM 1 DI 1 IM 2 DI 2 Maintenance
2 BM MRD 001 after IM 1 Change to Very high risk regimen
T cell ALL patients with M1 BM post-Consolidation will start IM 1 However the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD 001 has been reported
Study Oversight
Has Oversight DMC:
None
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?:
None