Official Title
ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012
Brief Title
ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia
Protocol ID
NCT02619071
Lead Sponsor
Institut Paoli-Calmettes
Brief Summary
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 Count
87 participants
Eligibility Criteria
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.
Filters
Leukemia, Myeloid, Acute
NA
UNKNOWN
ADULT
OLDER_ADULT