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NCT Number: NCT06130787

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

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.

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Key information

Conditions

Leukemia,Myeloid, Chronic Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Annecy-Genevois, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and bone marrow sample

Biological

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 outcomes

  1. Biological age determination

    Time frame: 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.

  2. Individual fragility assessment

    Time frame: 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.

  3. Individual fragility assessment

    Time frame: 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)

  4. Tolerance of tyrosine kinase inhibitors

    Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

    Tolerance assessed by actual dose received

  5. Tolerance of tyrosine kinase inhibitors

    Time frame: 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

  6. Tolerance of tyrosine kinase inhibitors

    Time frame: 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

  7. Tolerance of tyrosine kinase inhibitors

    Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

    Tolerance assessed by changes and number of tyrosine kinase inhibitor lines

  8. Tolerance of tyrosine kinase inhibitors

    Time frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

    Tolerance assessed by a description of treatment sequences

Secondary outcomes

  1. Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis.

    Time frame: 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.

  2. Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis.

    Time frame: 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.

  3. 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

    Quantification of BCR::ABL transcript expressed as copy number relative to 100 copies of control gene transcripts

  4. 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

    Decrease in residual disease and achievement of MMR (≤0.1%), MR4 (≤0.01%), MR4.5 (≤0.032%), MR5 (≤0.001%) thresholds)

  5. Assessment of patients' quality of life

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LACLAUTRE

CONTACT

[email protected]

+33473754963

Mélanie CASILE, PhD

CONTACT

[email protected]

+33473750682

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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.

Acronym: BIO-TIMER

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Nov 14, 2023
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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