Viewing Study NCT06451861



Ignite Creation Date: 2024-06-16 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06451861
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-11
First Post: 2024-02-05

Brief Title: Randomized Study of ABC-14 Regimen Compared With 37 Standard Induction Therapy or AB-14 for ND AML
Sponsor: Guangdong Provincial Peoples Hospital
Organization: Guangdong Provincial Peoples Hospital

Study Overview

Official Title: Randomized Study of ABC-14 Regimen AZA Venetoclax and Chidamide Compared With 37 Standard Induction Therapy or AB-14 Venetoclax Combined With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-01
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: To compare the efficacy and safty of ABC-14 regimen with the traditional 37 regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia
Detailed Description: Acute myeloid leukemia AML is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cellsIn the past 50 years the 37 induction regimen represented by cytotoxic drugs including anthracyclinesanthraquinones combined with cytarabine has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy In AML patients 60 years old the 37 regimen induces a complete response rate of 60 to 80 but the treatment-related mortality is as high as 13 and more than half of the patients face the threat of relapse and the 5-year overall survival rate is about 35 to 40

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