We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Phase
Leukemia, Myeloid, Acute Procedure: Tumor sampling Biological: Constiutional DNA sampling Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Dominique Genre, MD +33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD,PhD +33491223778 drci.up@ipc.unicancer.fr

Locations
Layout table for location information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02619071    
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:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms