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ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia (CeGAL)

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ClinicalTrials.gov Identifier: NCT02619071
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : June 28, 2016
Sponsor:
Collaborator:
Cancer Research Center of Marseille
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Leukemia, Myeloid, Acute Procedure: Tumor sampling Biological: Constiutional DNA sampling

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012
Study Start Date : August 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017


Arm Intervention/treatment
Experimental: Refractory or relapsed acute myeloid leukemia Procedure: Tumor sampling
Bone marrow aspirate, blood sampling
Biological: Constiutional DNA sampling
Buccal swab or Hair follicles



Primary Outcome Measures :
  1. 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. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619071


Contacts
Contact: Dominique Genre, MD +33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD,PhD +33491223778 drci.up@ipc.unicancer.fr

Locations
France
Institut PAOLI-CALMETTES Recruiting
Marseille, France
Contact: Dominique GENRE, MD    (33)4 91 22 37 78    drci.up@ipc.unicancer.fr   
Contact: Jihane PAKRADOUNI, PharmD,PhD    (33)4 91 22 37 78    drci.up@ipc.unicancer.fr   
Principal Investigator: Norbert VEY, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Cancer Research Center of Marseille

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02619071     History of Changes
Other Study ID Numbers: CeGAL-IPC-2014-012
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Institut Paoli-Calmettes:
acute myeloid leukemia- refractory AML- relapsed AML- precision medecine-

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms