EPIgenetics and in Vivo Resistance of Chronic Myeloid Leukemia Stem Cells to Tyrosine Kinase Inhibitors
EPIK
Collection of Biological Resources During Medical Care of Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase for an Epigenetic Study of Leukemic Stem Cells
2 other identifiers
interventional
160
1 country
16
Brief Summary
Primary objective : To identify epigenetic dysregulations of in vivo TKI-resisting CML cells Hypothesis : An epigenetic dysregulation is involved in the in vivo survival of a CML cell subclone despite the use of TKIs
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedApril 9, 2024
April 1, 2024
7.2 years
February 1, 2018
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Epigenetic dysregulations of in vivo TKI-resisting CML cells
Epigenetic and/or gene expression anomalies in in vivo TKI-selected CML cells for 3 months in comparison with anomalies identified at D0
at Day 0 and Month3
Secondary Outcomes (3)
relationship between epigenetic/gene expression profile and CML burden (M3)
at Month 3
relationship between epigenetic/gene expression profile and the characteristics of patients
at Day 0 and Month 3
early new biomarkers
at Day 0 and Month 3
Study Arms (1)
Chronic Myeloid Leukemia
EXPERIMENTALPatients newly diagnosed for Chronic Myeloid Leukemia, according to inclusion and exclusion criteria
Interventions
Collection of blood and bone marrow in order to identify epigenetic abnormalities and their consequences in surviving CML cells after 3 months of TKI treatment
Eligibility Criteria
You may qualify if:
- Patient newly diagnosed for Chronic Myeloid Leukemia in chronic phase
- Patient older than 18 years old
- Patient who received no treatment for CML at the time of sampling on D0
- Intention of prescription with first-line treatment with TKI only
- Choice of first-line CML treatment by TKI only
- Patient having signed an informed consent
- Patient with a social security system
You may not qualify if:
- Contra-indication to the use of TKI
- Probability of poor compliance during treatment
- Patients already treated for CML
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Institut Paoli-Calmettescollaborator
- CHRU Lille, hematology departmentcollaborator
- CH Annecy Genevoiscollaborator
- Institut Bergonié Bordeaux, hematology departmentcollaborator
- Central Hospital, Nancy, Francecollaborator
- CHU Saint-Etienne, hematology departmentcollaborator
- Institut Universitaire du Cancer de Toulousecollaborator
- CHU Caen, hematology departmentcollaborator
- CHU Nice, hematology departmentcollaborator
- Hospices Civils de Lyoncollaborator
- AP-HP, hematology departmentcollaborator
- AP-HP Hôpital Henri-Mondor, hematology departmentcollaborator
- Versailles Hospitalcollaborator
- Centre Leon Berardcollaborator
- University Hospital, Grenoblecollaborator
Study Sites (16)
CHU Annecy-Genevois
Annecy, France
Institut Bergonié
Bordeaux, France
CHU Caen
Caen, France
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
CHU Grenoble Alpes
Grenoble, France
CHU Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hospices Civils de Lyon
Lyon, France
CHU Nancy
Nancy, France
CHU Nice
Nice, France
Hôpital Bicêtre
Paris, France
Hôpital Henri Mondor
Paris, France
Hôpital Paul Brousse
Paris, France
Hôpital Saint Louis
Paris, France
CHU Saint-Etienne
Saint-Etienne, France
CHU Versailles
Versailles, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc BERGER
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2018
First Posted
March 29, 2018
Study Start
February 1, 2018
Primary Completion
May 1, 2025
Study Completion
February 1, 2026
Last Updated
April 9, 2024
Record last verified: 2024-04