Clinical trial NCT02619071: ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia
Official title: ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia, Myeloid, Acute
Keywords: acute myeloid leukemia- refractory AML- relapsed AML- precision medecine-
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Cancer Research Center of Marseille
First posted: 2015-12-02
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


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.

Primary outcomes:
measure: The proportion of patients for whom a treatment tailored according to chemogenomic data could be proposed to the investigator within a 21 days time-frame in at least 30% of cases.
timeFrame: 24 months
Secondary outcomes:
measure: Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut PAOLI-CALMETTES
Study officials:
References:
citation: Collignon A, Hospital MA, Montersino C, Courtier F, Charbonnier A, Saillard C, D'Incan E, Mohty B, Guille A, Adelaide J, Carbuccia N, Garnier S, Mozziconacci MJ, Zemmour C, Pakradouni J, Restouin A, Castellano R, Chaffanet M, Birnbaum D, Collette Y, Vey N. A chemogenomic approach to identify personalized therapy for patients with relapse or refractory acute myeloid leukemia: results of a prospective feasibility study. Blood Cancer J. 2020 Jun 3;10(6):64. doi: 10.1038/s41408-020-0330-5.