Assessing biological age and frailty in newly diagnosed chronic leukemia patients for personalized treatment
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.
NA · University Hospital, Clermont-Ferrand · NCT06130787
This study is testing how to personalize treatment for newly diagnosed chronic myeloid leukemia patients by looking at their biological age and overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 321 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 17 sites (Annecy and 16 other locations) |
| Trial ID | NCT06130787 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been newly diagnosed with chronic-phase CML within the last three months.
Not a fit: Patients with CML in accelerated or blast phase, or those who have started treatment prior to inclusion, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more tailored and effective treatment strategies for patients with chronic myeloid leukemia.
How similar studies have performed: While the specific combination of biological age and frailty assessment in CML is novel, similar approaches in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Annecy and 16 other locations
- CHU Annecy-Genevois — Annecy, France (RECRUITING)
- Institut Bergonié — Bordeaux, France (NOT_YET_RECRUITING)
- CHU Caen — Caen, France (RECRUITING)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- CHU Créteil — Créteil, France (NOT_YET_RECRUITING)
- CHU Grenoble Alpes — Grenoble, France (NOT_YET_RECRUITING)
- Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (RECRUITING)
- CHRU Lille — Lille, France (NOT_YET_RECRUITING)
- CHU Limoges — Limoges, France (RECRUITING)
- Centre Léon Bérard — Lyon, France (WITHDRAWN)
- Institut Paoli-Calmettes — Marseille, France (RECRUITING)
- CHU Nancy — Nancy, France (RECRUITING)
- Groupe Hospitalier Paris Saclay - Site de Bicêtre — Paris, France (RECRUITING)
- CHU Rennes — Rennes, France (RECRUITING)
- CHU Saint-Etienne — Saint-Etienne, France (RECRUITING)
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (RECRUITING)
- CHU Versailles — Versailles, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leukemia,Myeloid, Chronic