Status:
RECRUITING
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Leukemia,Myeloid, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
French prospective multicenter, open-label study involving newly diagnosed CML patients. Two assessments will be performed during the follow-up of these patients: individual frailty using geriatric to...
Eligibility Criteria
Inclusion
- Age ≥18 years
- CML in chronic phase at time of diagnosis. Diagnosis must be made no more than 3 months (90 days) prior to inclusion. Diagnosis of chronic-phase CML (European Leukemia Network \[ELN\] 2020 criteria; Baccarani et al 2013) with confirmation of a Philadelphia chromosome (Ph1). A cryptic Ph1 chromosome must be confirmed by FISH.Criteria must meet the definition of chronic phase CML
- BCR ::ABL1 transcript quantifiable by quantitative PCR
- 1st-line treatment with tyrosine kinase inhibitor
- No tyrosine kinase inhibitor or hydroxyurea treatment received prior to first blood sampling (at diagnosis)
- Signature of informed consent for CML Observatory and signature of informed consent for BIO-TIMER protocol
- Read and understand French
- Enrolled in a social security plan or beneficiary of such a plan
Exclusion
- CML in accelerated or blast phase
- Refusal to participate in the study
- Treatment started prior to inclusion
- Patients under guardianship, curatorship, deprivation of liberty or safeguard of justice
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 17 2028
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT06130787
Start Date
November 17 2023
End Date
November 17 2028
Last Update
September 27 2024
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Annecy-Genevois
Annecy, France
2
Institut Bergonié
Bordeaux, France
3
CHU Caen
Caen, France
4
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000