Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458244
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-01-09
Brief Title:
The Efficacy of Allo-HSCT in ND HR-CBF-AML
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk Core-binding-factor 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 core-binding-factor acute myeloid leukemia participants the investigators aim to perform allogeneic hematopoietic stem cell transplantation after participants finished one cycle of induction and two cycles of consolidation To access whether the therapeutic regimen is effective for high-relapse-risk core-binding-factor acute myeloid leukemia the disease-free-survival DFS overall survival OS non-relapse-mortality of participants is evaluated
Detailed Description:
High-relapse-risk definition
Participants with high-risk gene mutations or complex karyotypes for disease recurrence or flow cytometrygene MRD positivity after two chemotherapy treatments High-risk gene mutations include TP53 RTKRAS signaling FLT3 NRAS KRAS KIT JAK2 CSF3R chromatin modification ASXL1 ASXL2 KMD6A EZH2 SETD2 or mutations listed as intermediate-risk or high-risk in the 2022NCCN guidelines 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 high-risk gene mutations or complex karyotypes for disease recurrence or flow cytometrygene MRD positivity after two chemotherapy treatments High-risk gene mutations include TP53 RTKRAS signaling FLT3 NRAS KRAS KIT JAK2 CSF3R chromatin modification ASXL1 ASXL2 KMD6A EZH2 SETD2 or mutations listed as intermediate-risk or high-risk in the 2022NCCN guidelines 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