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Validation in clinical outcomes of acute myeloid leukemia patients harboring RUNX1 mutation: a single-center cohort study and meta-analysis

Completed
Conditions
Patients aged above 18 years with de novo AML or secondary.
Patients aged above 18 years with de novo AML or secondary. and AML molecular mutation profile by next-generation sequencing.
Registration Number
TCTR20220921005
Lead Sponsor
Siriraj Hospital Mahidol University
Brief Summary

The study enrolled 135 patients divided into two groups based on the presence of RUNX1 mutation. Among them, 27 patients were RUNX1mut patients while 108 were RUNX1wt patients. The cohort is median age was 55 years interquartile range. However the patients in the RUNX1mut group were significantly older than those in the RUNX1wt group with median ages of 62 years and 53 years.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
135
Inclusion Criteria

(1) Patients aged above 18 years
(2) Patients with de novo AML or secondary AML
(3) Patients with molecular mutation profile by next-generation sequencing
(4) Patients who signed informed consent of AML registry study (793/2560 (EC2)

Exclusion Criteria

(1)Patients diagnosed acute promyelocytic leukemia (APL)

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparing 1-year OS rate between RUNX1 mutation and RUNX1 wild-type groups 1 year The duration between diagnosis and either death or last follow-up
Secondary Outcome Measures
NameTimeMethod
Comparing CR rates between RUNX1 mutation and RUNX1 wild-type groups 2 months The percentage of patients who have BM blasts below 5%, the absence of extramedullary blasts, with an ANC more than 1000/mcL, and a plt more than 100000/mcL after induction treatment, Comparing 1-year RFS rate between RUNX1 mutation and RUNX1 wild-type groups 1 year The duration from the CR date to relapse or death from any cause,Studying significant factors associated with OS and RFS 1 year Comparing factors associated with survival outcomes between RUNX1 mutation and RUNX1 wild-type groups
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