Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-01-09
Brief Title:
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
For newly diagnosed high-relapse-risk CEBPA mutant acute myeloid leukemia patients we aim to perform allogeneic hematopoietic stem cell transplantation after patients finished one cycle of induction and two cycles of consolidation To access whether the therapeutic regimen is effective for high-relapse-risk CEBPA mutant acute myeloid leukemia the disease-free-survival DFS overall survival OS non-relapse-mortality of patients is evaluated
Detailed Description:
High-relapse-risk definition
Participants with non-bZIP in-frame mutations WT1 mutated status or CD7 negative status are considered of high-relapse-risk The positive threshold for flow cytometry MRD was 00001 The MRD threshold of molecular biology is the lowest value of the detection protocol of the center
Participants with non-bZIP in-frame mutations WT1 mutated status or CD7 negative status are considered of high-relapse-risk The positive threshold for flow cytometry MRD was 00001 The MRD threshold of molecular biology is the lowest value of the detection protocol of the center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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