Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated With Targeted Therapy: the Model of Chronic Myeloid Leukemia Treated With Tyrosine Kinase Inhibitors.

RBHP 2023 BERGER

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 tools and individual biological aging determined by DNA methylation analysis.

2023-11-17

2025-11-17

2028-11-17

Recruiting

321

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 321, 'type': 'ESTIMATED'}}

2024-03-01