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

NCT07004816 | Terminated

• 1 other identifier: IIT2017004
• Study Type: observational
• Target: 1,015
• Locations: 1 country
• Sites: 1

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.

Conditions

AML

Outcome Measures

Primary Outcomes (1)

• Incidence

  Incidence is defined as the incidence of patients who carries IDH1/2 mutations

  Before treatment

Secondary Outcomes (2)

• Relapse-Free Survival(RFS)

  Up to 3 years

• Overall Survival(OS)

  Up to 3 years

Study Arms (1)

AML patients

Uncover mutation profiles of newly-diagnosed AML patients

Other: Uncover mutation profiles

Interventions

Uncover mutation profiles OTHER

Uncover mutation profiles

AML patients

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Age of less than 60 years old;
• Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
• 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.

You may not qualify if:

• Patients with other blood diseases(for example, haemophiliacs) are excluded.
• With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
• Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
• Had other malignant tumor in need of treatment;
• Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: December 21, 2017
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: November 18, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)