NCT07004816

The Mutation Profile and Prognosis in AML With IDH1/2 Mutation

The Mutation Profile and Prognosis in Acute Myeloid Leukemia With IDH1/2 Mutation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,015 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Also, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China and elucidate the prognostic effect of IDH1/2 mutation in AML.

Detailed description

In this program, first, investigators want to uncover mutation profiles in the 500 AML patients including AML1-ETO CBFb-MYH11, MLL translocation, NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11 genetic alteration in addition to IDH1/2 mutation. These patients received regimen, which is consistent with NCCN and ELN guidelines. NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11, and IDH1/2 genetic alteration will be detected by targeted next generation sequencing. AML1-ETO and CBFb-MYH11 will be detected by RT-PCR. MLL translocation will be detected by FISH(fluorescence in situ hybridization).Next, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China. Then investigators will investigate mutation profile in IDH1/2 mutation AML patients. Finally, investigators will elucidate the prognostic effect of IDH1/2 mutation in AML. At last, investigators will instigate how mutation profile affects the prognosis in IDH1/2 mutation AML patients.

Conditions

• AML

Interventions

Type	Name	Description
OTHER	Uncover mutation profiles	Uncover mutation profiles

Timeline

• Start date: 2017-12-21
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2025-06-04
• Last updated: 2025-11-18

Locations

1 site across 1 country: China