About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Blood and bone marrow sample
Biological/VaccineIndividual biological aging determined by DNA methylation analysis will be assessed at D0, M3 and M12. An optional bone marrow sample will be taken during the myelogram performed at diagnosis. Individual fragility and quality of life will be assessed using geriatric tools at D0, M6, M12, M24 and M36
Treatment groups
Trial outcomes
Primary outcomes
Biological age determination
The difference between biological age and chronological age (of the clone and the patient) expressed as a difference and as a percentage.
Individual fragility assessment
Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.
Individual fragility assessment
Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)
Tolerance of tyrosine kinase inhibitors
Tolerance assessed by actual dose received
Secondary outcomes
Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis.
Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities at the time of diagnosis.
Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis.
Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life) at the time of diagnosis.
Evaluation of therapeutic response through quantification of the BCR::ABL transcript
Quantification of BCR::ABL transcript expressed as copy number relative to 100 copies of control gene transcripts
Assessment of therapeutic response by quantification of residual disease
Decrease in residual disease and achievement of MMR (≤0.1%), MR4 (≤0.01%), MR4.5 (≤0.032%), MR5 (≤0.001%) thresholds)
Sponsors and contacts
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