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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
321
Individual 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
CHU Annecy-Genevois
Annecy, France
RECRUITINGInstitut Bergonié
Bordeaux, France
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.
Time frame: Day 0;Month 3;Month 12
Individual fragility assessment
Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.
Time frame: Day 0;Month 6;Month 12;Month 24;Month 36
Individual fragility assessment
Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)
Time frame: Day 0;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Tolerance assessed by actual dose received
Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Tolerance assessed by the number of tyrosine kinase inhibitor discontinuation due to intolerance
Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Tolerance assessed by a description of adverse events as assessed by CTCAE v5.0
Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Tolerance assessed by changes and number of tyrosine kinase inhibitor lines
Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
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CHU Caen
Caen, France
RECRUITINGCHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCHU Créteil
Créteil, France
NOT_YET_RECRUITINGCHU Grenoble Alpes
Grenoble, France
NOT_YET_RECRUITINGCentre Hospitalier Emile Roux
Le Puy-en-Velay, France
RECRUITINGCHRU Lille
Lille, France
NOT_YET_RECRUITINGCHU Limoges
Limoges, France
RECRUITINGCentre Léon Bérard
Lyon, France
WITHDRAWN...and 7 more locations
Tolerance assessed by a description of treatment sequences
Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
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.
Time frame: Day 0
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.
Time frame: Day 0
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
Time frame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
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)
Time frame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
Assessment of patients' quality of life
Quality of life assessed using the European Organisation for Research and Treatment of Cancer LG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients, with a higher score indicating a better health-related quality of life
Time frame: Day 0;Month 6;Month 12;Month 24;Month 36