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

NCT ID: NCT07004816

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1015 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2020-03-24

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AML patients

Uncover mutation profiles of newly-diagnosed AML patients

Uncover mutation profiles

Intervention Type: OTHER

Uncover mutation profiles

Interventions

Uncover mutation profiles

Uncover mutation profiles

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age of less than 60 years old;

2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).

3. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Exclusion Criteria

1. Patients with other blood diseases(for example, haemophiliacs) are excluded.

2. With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;

3. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;

4. Had other malignant tumor in need of treatment;

5. Patients with other factors which were considered unsuitable to participate in the study by the investigators.

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

IIT2017004

Identifier Type: -

Identifier Source: org_study_id