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.

Conditions

• Leukemia,Myeloid, Chronic

Intervention / Treatment

• Biological: Blood and bone marrow sample

Primary Outcome Measures

• 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 Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.
• 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 actual dose received
• Tolerance of tyrosine kinase inhibitors (Day 0;Month 3;Month 6;Month 12;Month 24;Month 36)
  Tolerance assessed by the number of tyrosine kinase inhibitor discontinuation due to intolerance
• Tolerance of tyrosine kinase inhibitors (Day 0;Month 3;Month 6;Month 12;Month 24;Month 36)
  Tolerance assessed by a description of adverse events as assessed by CTCAE v5.0
• Tolerance of tyrosine kinase inhibitors (Day 0;Month 3;Month 6;Month 12;Month 24;Month 36)
  Tolerance assessed by changes and number of tyrosine kinase inhibitor lines
• 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

Countries

France

Locations and Investigators

• CHU Annecy-Genevois, Annecy, France (Recruiting)
  • Anne PARRY, MD
• Institut Bergonié, Bordeaux, France (Not yet recruiting)
  • Gabriel ETIENNE, MD
• CHU Caen, Caen, France (Recruiting)
  • Atchroue JOHNSON ANSAH, MD
• CHU de Clermont-Ferrand, Clermont-Ferrand, France (Recruiting)
  • Marc BERGER, Pr
  • Melanie CASILE, PhD
  • Eric HERMET, MD
  • Clément LAHAYE, MD
• CHU Créteil, Créteil, France (Not yet recruiting)
  • Lydia ROY, MD
• CHU Grenoble Alpes, Grenoble, France (Not yet recruiting)
  • Mathieu MEUNIER, MD
• Centre Hospitalier Emile Roux, Le Puy-en-Velay, France (Recruiting)
  • Vanessa PANTE, Dr
  • Vanessa PANTE, MD
• CHRU Lille, Lille, France (Not yet recruiting)
  • Valérie COITEUX, MD
• CHU Limoges, Limoges, France (Recruiting)
  • Amélie PENOT, MD
  • Jean Baptiste FARGEAS, MD
• Centre Léon Bérard, Lyon, France (Withdrawn)
• Institut Paoli-Calmettes, Marseille, France (Recruiting)
  • Aude CHARBONNIER, MD
• CHU Nancy, Nancy, France (Recruiting)
  • Gabrielle ROTH-GUEPI, MD
  • Jean-Yves NIEMIER, MD
• Groupe Hospitalier Paris Saclay - Site de Bicêtre, Paris, France (Recruiting)
  • Laurence LEGROS, MD
  • Emanuelle DURON, MD
• CHU Rennes, Rennes, France (Recruiting)
  • Martine ESCOFFRE-BARBE, MD
• CHU Saint-Etienne, Saint-Étienne, France (Recruiting)
  • Philippe RENAUDIER, MD
  • Blandine DELAVIGERIE, MD
• Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, France (Recruiting)
  • Françoise HUGUET, MD
  • Clément GAUDIN, MD
• CHU Versailles, Versailles, France (Recruiting)
  • Philippe ROUSSELOT, Pr

Study Officials

• Marc BERGER (Principal Investigator) — University Hospital, Clermont-Ferrand