Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Blood and bone marrow sample

    Biological/Vaccine

    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

Treatment groups

321 Participants
are divided into 1 treatment group
Group A: All patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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