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NCT04242849 Clinical Trial

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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04242849
Other study ID # N/A-NI-AML-PI-007344
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 23, 2016
Est. completion date January 16, 2020

Study information
Verified date January 2020
Source Josep Carreras Leukaemia Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 354
Est. completion date January 16, 2020
Est. primary completion date December 27, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Josep Carreras Leukaemia Research Institute Celgene

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of IDH1/2 mutation Detection of mutations in IDH1 and IDH2 genes 1 day
Secondary Detection of co-mutations Screening of aditional mutations in those cases with IDH1/2 mutation 1 day
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