Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607419
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBClean
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy ie day 19 MRD 01 low-risk or day 19 MRD 001 intermediate-risk The main question is
If the flow cytometric MRD negative 001 rate and the NGS- MRD negative 00001 rate at the end of induction for patients received Blinatumomab will be superior to historical control D46MRD in the CCCG-ALL2020 protocol
Participants will
Take 14 days full dose Blinatumomab
With bone marrow evaluated before and after Blinatumomab treatment
If the flow cytometric MRD negative 001 rate and the NGS- MRD negative 00001 rate at the end of induction for patients received Blinatumomab will be superior to historical control D46MRD in the CCCG-ALL2020 protocol
Participants will
Take 14 days full dose Blinatumomab
With bone marrow evaluated before and after Blinatumomab treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None