Assessing biological age and frailty in newly diagnosed chronic leukemia patients for personalized treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a French multicenter, open-label investigation focusing on newly diagnosed patients with chronic myeloid leukemia (CML). It aims to evaluate individual frailty using geriatric assessment tools alongside biological aging determined through DNA methylation analysis. Patients will undergo blood and bone marrow sampling to gather necessary data for these assessments during their follow-up. The goal is to personalize management strategies for patients receiving targeted therapy based on their biological and frailty profiles.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Annecy-Genevois
  Annecy, France Recruiting
• CHU Caen
  Caen, France Recruiting
• CHU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Centre Hospitalier Emile Roux
  Le Puy-en-Velay, France Recruiting
• CHU Limoges
  Limoges, France Recruiting
• Institut Paoli-Calmettes
  Marseille, France Recruiting

Study contacts

• Principal investigator: Marc BERGER — University Hospital, Clermont-Ferrand
• Study coordinator: Lise LACLAUTRE
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.