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Leukemia,Myeloid, ChronicBIO-TIMERNCT06130787

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

A study testing Blood and bone marrow sample in people with Leukemia,Myeloid, Chronic, run by University Hospital, Clermont-Ferrand at 17 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia,Myeloid, Chronic
What is being tested?
Blood and bone marrow sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
17 sitesFrance
Study dates
17 Nov 2023to 17 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise LACLAUTRE contact

+33473754963

promo_interne_drci@chu-clermontferrand.fr

Mélanie CASILE, PhD contact

+33473750682

mcasile@chu-clermontferrand.fr

17 sites in 1 country

France17 sites, 16 recruiting

  • CHU Annecy-Genevois

    Annecy

    Anne PARRY, MD

    Recruiting

  • Institut Bergonié

    Bordeaux

    Gabriel ETIENNE, MD

    Not yet recruiting

  • CHU Caen

    Caen

    Atchroue JOHNSON ANSAH, MD

    Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Marc BERGER, Pr, mberger@chu-clermontferrand.fr

    Melanie CASILE, PhD, +33473750682, mcasile@chu-clermont.fr

    Recruiting

  • CHU Créteil

    Créteil

    Lydia ROY, MD

    Not yet recruiting

  • CHU Grenoble Alpes

    Grenoble

    Mathieu MEUNIER, MD

    Not yet recruiting

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay

    Vanessa PANTE, Dr

    Vanessa PANTE, MD

    Recruiting

  • CHRU Lille

    Lille

    Valérie COITEUX, MD

    Not yet recruiting

  • CHU Limoges

    Limoges

    Amélie PENOT, MD

    Jean Baptiste FARGEAS, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Withdrawn

  • Institut Paoli-Calmettes

    Marseille

    Aude CHARBONNIER, MD

    Recruiting

  • CHU Nancy

    Nancy

    Gabrielle ROTH-GUEPI, MD

    Jean-Yves NIEMIER, MD

    Recruiting

  • Groupe Hospitalier Paris Saclay - Site de Bicêtre

    Paris

    Laurence LEGROS, MD

    Emanuelle DURON, MD

    Recruiting

  • CHU Rennes

    Rennes

    Martine ESCOFFRE-BARBE, MD

    Recruiting

  • CHU Saint-Etienne

    Saint-Etienne

    Philippe RENAUDIER, MD

    Blandine DELAVIGERIE, MD

    Recruiting

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse

    Françoise HUGUET, MD

    Clément GAUDIN, MD

    Recruiting

  • CHU Versailles

    Versailles

    Philippe ROUSSELOT, Pr

    Recruiting

Other trials in France

About this study

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.

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.

Being tested
Blood and bone marrow sample
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood and bone marrow sampleBiological

    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

Study groups in NCT06130787
Study groupRoleWhat they receive
All patientsExperimentalNot described
Receives: Biological: Blood and bone marrow sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biological age determination

    The difference between biological age and chronological age (of the clone and the patient) expressed as a difference and as a percentage.

    Measured: Day 0;Month 3;Month 12

  2. Individual fragility assessment

    Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.

    Measured: Day 0;Month 6;Month 12;Month 24;Month 36

  3. Individual fragility assessment

    Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)

    Measured: Day 0;Month 6;Month 12;Month 24;Month 36

  4. Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by actual dose received

    Measured: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

  5. Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by the number of tyrosine kinase inhibitor discontinuation due to intolerance

    Measured: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

  6. Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by a description of adverse events as assessed by CTCAE v5.0

    Measured: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

  7. Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by changes and number of tyrosine kinase inhibitor lines

    Measured: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

  8. Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by a description of treatment sequences

    Measured: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

Secondary outcomes (5)

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

    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.

    Measured: Day 0

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

    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.

    Measured: Day 0

  3. Evaluation of therapeutic response through quantification of the BCR::ABL transcript

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

    Measured: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36

  4. Assessment of therapeutic response by quantification of residual disease

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

    Measured: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36

  5. Assessment of patients' quality of life

    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

    Measured: Day 0;Month 6;Month 12;Month 24;Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start17 Nov 2023
  3. Primary completion17 Nov 2025 (estimated)
  4. Study completion17 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
321 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06130787
Sponsor's protocol ID
RBHP 2023 BERGER
Other IDs
2023-A00974-41
Acronym
BIO-TIMER
Status last verified
Sep 2024
First submitted
29 Sep 2023
Last updated
27 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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/s12885-024-12415-2.

    PubMed 38816821

Questions about this trial

What is this clinical trial studying?

A study testing Blood and bone marrow sample in people with Leukemia,Myeloid, Chronic, run by University Hospital, Clermont-Ferrand at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biological age determination (time frame: Day 0;Month 3;Month 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06130787, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.

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