ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia (CeGAL)

Institut Paoli-Calmettes

Status: Unknown

Conditions: Leukemia, Myeloid, Acute

Treatments: Procedure: Tumor sampling; Biological: Constiutional DNA sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02619071

CeGAL-IPC-2014-012

Details and patient eligibility

About

Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with poor prognosis, especially after relapse. High-throughput genomic studies have highlighted the importance of molecular alteration in the pathophysiology, clinical evolution and treatment response of AML. In addition, identification of specific gene mutation can be targeted by specific inhibitors, opening the way to personalized treatments. However, only a limited number of gene mutations are druggable or actionable, highlighting the need for additional information to guide treatment choices. Among them, new Drug Screening Tests (DST) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells. Combination of genomic and pharmacologic approaches might therefore improve prediction of drug effects. There is an urgent need to bring these approaches into the clinic but feasibility trials are necessary before incorporating them into treatments strategies.The proposed study is a prospective multicentre feasibility study of a combined "chemo-genomic" approach in patients with advanced AML.

Enrollment: 87 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Diagnosis of acute myeloid leukemia according to WHO classification
• Refractory or relapsed disease
• ECOG performance status of <3
• Life expectancy >3 months
• Written informed consent
• Affiliation to the French Social Security System.

Exclusion criteria

• Diagnosis of Acute Promyelocytic Leukemia.
• Patients deprived of liberty or placed under the authority of a tutor.

Trial design

87 participants in 1 patient group

Refractory or relapsed acute myeloid leukemia

Experimental group

Treatment:

Procedure: Tumor sampling

Biological: Constiutional DNA sampling