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

Not Applicable

Recruiting

• Conditions: Leukemia,Myeloid, Chronic
• Interventions: Biological: Blood and bone marrow sample

• Registration Number: NCT06130787
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-14
• Study Start: 2023-11-17
• Status Verified: 2023-12
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-11-17
• Study Completion: 2028-11-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 321

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Blood and bone marrow sample	-

Primary Outcome Measures

Name	Time	Method
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 Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)
Tolerance of tyrosine kinase inhibitors	Day 0;Month 3;Month 6;Month 12;Month 24;Month 36	Tolerance assessed by a description of treatment sequences

Secondary Outcome Measures

Name	Time	Method
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.
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
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
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)

Trial Locations

Locations (17)

Centre Hospitalier Emile Roux; 🇫🇷 Le Puy-en-Velay, 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

CHU Grenoble Alpes; 🇫🇷 Grenoble, 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, France