ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia

ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02619071

Acronym

CeGAL

Enrollment

Registered

2015-12-02

Start date

2015-08-31

Completion date

2017-08-31

Last updated

2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Acute

Keywords

acute myeloid leukemia- refractory AML- relapsed AML- precision medecine-

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.

Interventions

PROCEDURETumor sampling

Bone marrow aspirate, blood sampling

BIOLOGICALConstiutional DNA sampling

Buccal swab or Hair follicles

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

France

Contacts

Primary ContactDominique Genre, MD

drci.up@ipc.unicancer.fr+33491223778

Backup ContactJihane PAKRADOUNI, PharmD,PhD