Clinical trial NCT06130787: Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia,Myeloid, Chronic
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biological age determination
timeFrame: Day 0;Month 3;Month 12
measure: Individual fragility assessment
timeFrame: Day 0;Month 6;Month 12;Month 24;Month 36
measure: Individual fragility assessment
timeFrame: Day 0;Month 6;Month 12;Month 24;Month 36
measure: Tolerance of tyrosine kinase inhibitors
timeFrame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
measure: Tolerance of tyrosine kinase inhibitors
timeFrame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
measure: Tolerance of tyrosine kinase inhibitors
timeFrame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
measure: Tolerance of tyrosine kinase inhibitors
timeFrame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
measure: Tolerance of tyrosine kinase inhibitors
timeFrame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Secondary outcomes:
measure: Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis.
timeFrame: Day 0
measure: Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis.
timeFrame: Day 0
measure: Evaluation of therapeutic response through quantification of the BCR::ABL transcript
timeFrame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
measure: Assessment of therapeutic response by quantification of residual disease
timeFrame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
measure: Assessment of patients' quality of life
timeFrame: Day 0;Month 6;Month 12;Month 24;Month 36
Other outcomes:
Locations:
city: Annecy
country: France
facility: CHU Annecy-Genevois
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: CHU Créteil
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nancy
country: France
facility: CHU Nancy
city: Paris
country: France
facility: Groupe Hospitalier Paris Saclay - Site de Bicêtre
city: Rennes
country: France
facility: CHU Rennes
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
city: Versailles
country: France
facility: CHU Versailles
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marc BERGER
role: PRINCIPAL_INVESTIGATOR
References: