NCT06130787

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Nov 2023Nov 2028

First Submitted

Initial submission to the registry

September 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2028

Expected
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 29, 2023

Last Update Submit

September 26, 2024

Conditions

Leukemia,Myeloid, Chronic

Outcome Measures

Primary Outcomes (8)

  • 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.

    Day 0;Month 3;Month 12

  • Individual fragility assessment

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

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

  • Individual fragility assessment

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

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

  • Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by actual dose received

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

  • Tolerance of tyrosine kinase inhibitors

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

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

  • Tolerance of tyrosine kinase inhibitors

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

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

  • Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by changes and number of tyrosine kinase inhibitor lines

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

  • Tolerance of tyrosine kinase inhibitors

    Tolerance assessed by a description of treatment sequences

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

Secondary Outcomes (5)

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

    Day 0

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

    Day 0

  • Evaluation of therapeutic response through quantification of the BCR::ABL transcript

    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

    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

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

Study Arms (1)

All patients

EXPERIMENTAL
Biological: Blood and bone marrow sample

Interventions

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

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • BCR ::ABL1 transcript quantifiable by quantitative PCR
  • st-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

You may not qualify if:

  • CML in accelerated or blast phase
  • Refusal to participate in the study
  • Patients under guardianship, curatorship, deprivation of liberty or safeguard of justice
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU Annecy-Genevois

Annecy, France

RECRUITING

Institut Bergonié

Bordeaux, France

NOT YET RECRUITING

CHU Caen

Caen, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, 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

Related Publications (1)

  • 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.

    PMID: 38816821DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marc BERGER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Mélanie CASILE, PhD

CONTACT

+33473750682mcasile@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2023

First Posted

November 14, 2023

Study Start

November 17, 2023

Primary Completion

November 17, 2025

Study Completion (Estimated)

November 17, 2028

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(17)