Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing

Acute Myeloid Leukemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861651
• Other study ID #: M6-AML-14-004
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: August 5, 2016
• Start date: March 2014

Study information

• Verified date: July 2016
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: No authorization required
• Study type: Observational

Clinical Trial Summary

Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18 year

• Diagnosis of AML6

• Written consent obtained

Exclusion Criteria:

• No written consent

• No frozen samples

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Other:
• DNA sequencing

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille	Bouches-du Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular characterization of AML-6 by NGS and CGH array	Molecular characterization using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.	1 year	No