ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia

Not Applicable

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Procedure: Tumor sampling; Biological: Constiutional DNA sampling

• Registration Number: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refractory or relapsed acute myeloid leukemia	Tumor sampling	-
Refractory or relapsed acute myeloid leukemia	Constiutional DNA sampling	-

Primary Outcome Measures

Name	Time	Method
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.	24 months

Secondary Outcome Measures

Name	Time	Method
Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles	24 months

Trial Locations

Locations (1)

Institut PAOLI-CALMETTES; 🇫🇷 Marseille, France