Leukemia,Myeloid, Chronic
Conditions
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 tools and individual biological aging determined by DNA methylation analysis.
Interventions
BIOLOGICALBlood and bone marrow sample
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
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological age determination | Day 0;Month 3;Month 12 | 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 | Day 0;Month 6;Month 12;Month 24;Month 36 | Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities. |
| Tolerance of tyrosine kinase inhibitors | Day 0;Month 3;Month 6;Month 12;Month 24;Month 36 | Tolerance assessed by actual dose received |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of therapeutic response by quantification of residual disease | Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36 | Decrease in residual disease and achievement of MMR (≤0.1%), MR4 (≤0.01%), MR4.5 (≤0.032%), MR5 (≤0.001%) thresholds) |
| Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis. | Day 0 | 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. |
| Assessment of patients' quality of life | Day 0;Month 6;Month 12;Month 24;Month 36 | 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 |
| Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis. | Day 0 | 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 | Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36 | Quantification of BCR::ABL transcript expressed as copy number relative to 100 copies of control gene transcripts |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Backup ContactMélanie CASILE, PhD
Outcome results
None listed