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

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ClinicalTrials.gov Identifier: NCT02619071
Recruitment Status : Unknown
Verified June 2016 by Institut Paoli-Calmettes.
Recruitment status was:  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

November 30, 2015
December 2, 2015
June 28, 2016
August 2015
August 2017   (Final data collection date for primary outcome 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. [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT02619071 on ClinicalTrials.gov Archive Site
Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia
ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Leukemia, Myeloid, Acute
  • Procedure: Tumor sampling
    Bone marrow aspirate, blood sampling
  • Biological: Constiutional DNA sampling
    Buccal swab or Hair follicles
Experimental: Refractory or relapsed acute myeloid leukemia
Interventions:
  • Procedure: Tumor sampling
  • Biological: Constiutional DNA sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
87
Same as current
August 2017
August 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02619071
CeGAL-IPC-2014-012
No
Not Provided
Not Provided
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Cancer Research Center of Marseille
Not Provided
Institut Paoli-Calmettes
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP