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NCT05875649 Clinical Trial

A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure

AML Clinical Trial

— CLAG  

Official title:
A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05875649
Other study ID # NEFC-2023-162
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2, 2023
Est. completion date December 20, 2027

Study information
Verified date July 2023
Source Nanfang Hospital, Southern Medical University
Contact Xuejie Jiang, Doctor
Phone +86 18688869522
Email jxj3331233@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 137
Est. completion date December 20, 2027
Est. primary completion date August 20, 2027
Accepts healthy volunteers No
Gender All
Age group 14 Years to 65 Years
Eligibility Inclusion Criteria: - Acute myeloid leukemia patients with first-induction failure Exclusion Criteria: - Acute myeloid leukemia patients with serious infection and organ dysfunction.

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• CLAG
Acute myeloid leukemia patients are re-induced by CLAG Regimen after first-induction failure

Locations
Country Name City State
China Nanfang Hospital of Southern Medical University Guanzhou Guangdong
China Nanfang Hospital of Southern Medical University Guanzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure CLAG Regimen improves CR rate in acute myeloid leukemia patients with first-induction failure 6 months
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