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Recruiting NCT06130787

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

No phase Interventional Leukemia,Myeloid, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood and bone marrow sample.
Who it may be relevant to
Registry conditions: Leukemia,Myeloid, Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Biological age determination [Time frame: Day 0;Month 3;Month 12]
  • Individual fragility assessment [Time frame: Day 0;Month 6;Month 12;Month 24;Month 36]
  • Individual fragility assessment [Time frame: Day 0;Month 6;Month 12;Month 24;Month 36]
  • Tolerance of tyrosine kinase inhibitors [Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36]
  • Tolerance of tyrosine kinase inhibitors [Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36]
  • Tolerance of tyrosine kinase inhibitors [Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36]
  • Tolerance of tyrosine kinase inhibitors [Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36]
  • Tolerance of tyrosine kinase inhibitors [Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36]
Secondary outcome measures (5)
  • Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis. [Time frame: Day 0]
  • Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis. [Time frame: Day 0]
  • Evaluation of therapeutic response through quantification of the BCR::ABL transcript [Time frame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36]
  • Assessment of therapeutic response by quantification of residual disease [Time frame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36]
  • Assessment of patients' quality of life [Time frame: Day 0;Month 6;Month 12;Month 24;Month 36]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 17 centers
  • CHU Annecy-Genevois — Annecy
  • Institut Bergonié — Bordeaux
  • CHU Caen — Caen
  • CHU de Clermont-Ferrand — Clermont-Ferrand
  • CHU Créteil — Créteil
  • CHU Grenoble Alpes — Grenoble
  • Centre Hospitalier Emile Roux — Le Puy-en-Velay
  • CHRU Lille — Lille
  • … and 9 more centers

Publications

  • Casile M, Albrand G, Lahaye C, Lebecque B, Besombes J, Bourgne C, Pereira B, Saugues S, Jamot C, Hermet E, Berger MG. Value of combining biological age with assessment of individual frailty to optimize management of cancer treated with targeted therapies: model of chronic myeloid leukemia treated with tyrosine kinase inhibitors (BIO-TIMER trial). BMC Cancer. 2024 May 30;24(1):661. doi: 10.1186/s12 PMID 38816821

Identifiers

NCT: NCT06130787 · RBHP 2023 BERGER · 2023-A00974-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗