ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia

NCT ID: NCT02619071

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-08-31

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.

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Refractory or relapsed acute myeloid leukemia

Group Type: EXPERIMENTAL

Tumor sampling

Intervention Type: PROCEDURE

Bone marrow aspirate, blood sampling

Constiutional DNA sampling

Intervention Type: BIOLOGICAL

Buccal swab or Hair follicles

Interventions

Tumor sampling

Bone marrow aspirate, blood sampling

Intervention Type: PROCEDURE

Constiutional DNA sampling

Buccal swab or Hair follicles

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research Center of Marseille

OTHER

Sponsor Role: collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut PAOLI-CALMETTES

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Dominique Genre, MD

Role: CONTACT

drci.up@ipc.unicancer.fr

+33491223778

Jihane PAKRADOUNI, PharmD,PhD

Role: CONTACT

drci.up@ipc.unicancer.fr

+33491223778

Facility Contacts

Dominique GENRE, MD

Role: primary

drci.up@ipc.unicancer.fr

(33)4 91 22 37 78

Jihane PAKRADOUNI, PharmD,PhD

Role: backup

drci.up@ipc.unicancer.fr

(33)4 91 22 37 78

References

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.

Reference Type: DERIVED

PMID: 32488055 (View on PubMed)

Other Identifiers

CeGAL-IPC-2014-012

Identifier Type: -

Identifier Source: org_study_id