IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up

Josep Carreras Leukaemia Research Institute

Status: Completed

Conditions: Acute Myeloid Leukemia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04242849

N/A-NI-AML-PI-007344

Details and patient eligibility

About

In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year.

Among the cases with IDH1/2 mutations, targeted deep sequencing (TDS) of a panel covering coding regions of 40 myeloid related genes will be applied. With TDS, pyrosequencing results will be validated at the same time that prognosis value of co-mutated genes could be studied. Furthermore, with TDS, molecular architecture of IDH1 and IDH2 mutated cases might be better understood.

Enrollment: 354 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients >18 years old with de novo acute myeloid leukemia will be included. All patients will be treated according to clinical routine.

Exclusion criteria

• Patients not following the above criteria.

Trial design

354 participants in 2 patient groups

IDH1/2 mutated patients

Description:

Patients harboring mutations in IDH1 or IDH2 genes

Patients without IDH1/2 mutations

Description:

Patients that don´t present any mutation in IDH1/2 genes