- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619071
ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia (CeGAL)
June 27, 2016 updated by: Institut Paoli-Calmettes
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France
- Recruiting
- Institut Paoli-Calmettes
-
Contact:
- Dominique GENRE, MD
- Phone Number: (33)4 91 22 37 78
- Email: drci.up@ipc.unicancer.fr
-
Contact:
- Jihane PAKRADOUNI, PharmD,PhD
- Phone Number: (33)4 91 22 37 78
- Email: drci.up@ipc.unicancer.fr
-
Principal Investigator:
- Norbert Vey, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Refractory or relapsed acute myeloid leukemia
|
Bone marrow aspirate, blood sampling
Buccal swab or Hair follicles
|
What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
November 30, 2015
First Submitted That Met QC Criteria
November 30, 2015
First Posted (Estimate)
December 2, 2015
Study Record Updates
Last Update Posted (Estimate)
June 28, 2016
Last Update Submitted That Met QC Criteria
June 27, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CeGAL-IPC-2014-012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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