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

Leukemia,Myeloid, Chronic Clinical Trial

— BIO-TIMER  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06130787
• Other study ID #: RBHP 2023 BERGER
• Secondary ID: 2023-A00974-41
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: November 17, 2028

Study information

• Verified date: December 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 321
• Est. completion date: November 17, 2028
• Est. primary completion date: November 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia,Myeloid, Chronic

Intervention

Biological:
• Blood 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

Locations

Country	Name	City	State
France	CHU Annecy-Genevois	Annecy
France	Institut Bergonié	Bordeaux
France	CHU Caen	Caen
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU Créteil	Créteil
France	Centre Hospitalier Emile Roux	Le Puy-en-Velay
France	CHRU Lille	Lille
France	CHU Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	Institut Paoli-Calmettes	Marseille
France	CHU Nancy	Nancy
France	Groupe Hospitalier Paris Saclay - Site de Bicêtre	Paris
France	CHU Rennes	Rennes
France	CHU Saint-Etienne	Saint-Étienne
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse
France	CHU Versailles	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0;Month 3;Month 12
Primary	Individual fragility assessment	Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.	Day 0;Month 6;Month 12;Month 24;Month 36
Primary	Individual fragility assessment	Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)	Day 0;Month 6;Month 12;Month 24;Month 36
Primary	Tolerance of tyrosine kinase inhibitors	Tolerance assessed by actual dose received	Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Primary	Tolerance of tyrosine kinase inhibitors	Tolerance assessed by the number of tyrosine kinase inhibitor discontinuation due to intolerance	Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Primary	Tolerance of tyrosine kinase inhibitors	Tolerance assessed by a description of adverse events as assessed by CTCAE v5.0	Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Primary	Tolerance of tyrosine kinase inhibitors	Tolerance assessed by changes and number of tyrosine kinase inhibitor lines	Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Primary	Tolerance of tyrosine kinase inhibitors	Tolerance assessed by a description of treatment sequences	Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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	Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
Secondary	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)	Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
Secondary	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	Day 0;Month 6;Month 12;Month 24;Month 36