Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529250
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Controlled Clinical Trial of Intermediate-dose HAD Regimen for CEBPA Double-mutated Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-08
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:
HADCEBPA2023
Brief Summary:
AML is highly heterogeneous in pathogenesis and CEBPA double-mutated CEBPAdm AML is a common type of leukemia in China Currently no targeted therapies for CEBPAdm and chemotherapy and transplantation are still the treatment options for CEBPA double-mutated AML At present the 37 treatment induction regimen of cytarabine combined with anthracyclines is still the first-line recommended regimen In our retrospective study the intermediate dose HAD regimen produced a 3-year RFS of 847 and a 3-year OS of 928 in CEBPAdm AML Therefore this project intends to confirm the efficacy of intermediate-dose HAD in the treatment of CEBPA double-mutated AML is superior to the conventional treatment regimen through the multi-center RCT study
Detailed Description:
This is a prospective randomized controlled clinical trial of patients diagnosed with CEBPA double-mutated AML Patients who meet the inclusion criteria are randomly assigned to receive the intermediate-dose HAD regimen or the conventional 37 induction regimen IA or DA respectively When patients reach complete remission CR after the induction therapy 3 courses of the high-dose cytarabine regimen 3gm2 q12h 3 days are used Hematopoietic stem cell transplantation is recommended for patients with persistent MRD positive after treatment When patients do not achieve CR after the induction therapy reinduction therapy with IAC IDA 10mg m2 for 3 days cytarabine 100mgm2 for 7 days cyclophosphamide 350mgm2 d2 d5 regimen is used Patients who still do not achieve CR after reinduction therapy will be removed from the group
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