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RecruitingNCT05963061Updated Apr 9, 2024

Chronic Myeloid Leukemia (CML) Real-Life Database

An observational study in Chronic Myeloid Leukemia (CML), sponsored by University Hospital, Clermont-Ferrand. Recruiting at 14 sites in France. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by University Hospital, Clermont-Ferrand · Observational

From the registry’s dates

  • Started Apr 2014; still recruiting 12 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
3,500
Sex
All
01

Study summary

Establish the largest possible real-life cohort collecting long-term follow-up of a maximum number of CML patients in order to carry out observational studies: epidemiological, identification of subgroups according to their response to treatment, evaluation of new molecules in real life, therapeutic discontinuations, impact of the evolution of recommendations, etc.

Read the detailed description

Observational study collecting real-life clinico-biological data from patients with CML. Data are collected prospectively and retrospectively, from diagnosis and throughout the long-term follow-up of CML (follow up continues after treatment stopped).

02

Conditions studied

  • Chronic Myeloid Leukemia (CML)

Keywords

  • Leukemia
  • Leukemia, Myeloid
  • Chronic myeloid leukemia
  • Chronic, BCR::ABL Positive
  • Hematologic Malignancies
  • Tyrosine kinase inhibitor (TKI)
  • Targeted therapy
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 3,500 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any patient with a diagnose of CML

Inclusion criteria

  • Patient diagnosed for chronic myelocytic leukemia

Exclusion criteria

Exclusion Criteria:

  • CML allograft without TKI treatment
  • Refusal or inability to sign the consent
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
3,500 participants (estimated)
Target follow-up
30 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Clinical and biological data collection

    Aims of the registry are the collection of clinical data to gain further insights about patients's CML treated with ITK's (treatment, prognosis, therapeutical response).

    Time frame: Until death or last follow up (up to 30 years)

Secondary outcomes

  1. Prognosis score for CML (Sokal, ELTS, Eutos, Hasford)

    Time frame: At diagnosis

  2. BMI with evaluation of weight and height

    Time frame: Until death or last follow up (up to 30 years)

  3. Evaluation of major molecular response (MMR) with transcript BCR::ABL in %

    Time frame: Until death or last follow up (up to 30 years)

  4. Evaluation of molecular response MR4 with transcript BCR::ABL in %

    Time frame: Until death or last follow up (up to 30 years)

  5. Evaluation of molecular response MR4.5 with transcript BCR::ABL in %

    Time frame: Until death or last follow up (up to 30 years)

  6. Evaluation of molecular response MR5 with transcript BCR::ABL in %

    Time frame: Until death or last follow up (up to 30 years)

  7. Evaluation of cytogenetic response

    Time frame: Until death or last follow up (up to 30 years)

  8. Evaluation of TKI efficacy based on transcript BCR::ABL in %

    Time frame: Until death or last follow up (up to 30 years)

  9. Evaluation of TKI tolerance (adverses events)

    Time frame: Until death or last follow up (up to 30 years)

  10. Calcul in month of the duration of maintenance TFR (treatment free remission) after stop TKI for thérapeutic response

    Time frame: Until death or last follow up (up to 30 years)

  11. Listing of major medical history of patient's CML

    Time frame: Until death or last follow up (up to 30 years)

07

Study locations

14 of 14 sites recruiting
  • CH Annecy Genevois
    Annecy, France
    • Anne Parry, MD · Sub investigator
    Recruiting
  • University Hospital, Caen
    Caen, France
    • Atchroue Johnson Ansah, MD · Sub investigator
    Recruiting
  • CHU Clemront-Ferrand
    Clermont-Ferrand, France
    • Marc Berger, MD · Principal investigator
    Recruiting
  • Centre Hospitalier Emile Roux
    Le Puy-en-Velay, France
    • Vanessa Pante, MD · Sub investigator
    Recruiting
  • University Hospital, Limoges
    Limoges, France
    • Amelie Penot, MD · Sub investigator
    Recruiting
  • Institut Paoli-Calmettes
    Marseille, France
    • Aude CHARBONNIER, MD · Sub investigator
    Recruiting
  • Centre Hospital, Nancy
    Nancy, France
    • Agnès Guerci-Bresler, MD · Sub investigator
    Recruiting
  • Bicetre Hospital
    Paris, France
    • Ali Turhan, MD · Sub investigator
    Recruiting
  • Hopital Paul Brousse
    Paris, France
    • Laurence Legros, MD · Sub investigator
    Recruiting
  • Rennes University Hospital
    Rennes, France
    • Martine Escoffre-Barbe, MD · Sub investigator
    Recruiting
  • Centre Hospitalier de Rochefort
    Rochefort, France
    • Guillaume DENIS, MD · Sub investigator
    Recruiting
  • Centre Hospitalier Universitaire de Saint Etienne
    Saint-Étienne, France
    • Denis Guyotat, MD · Sub investigator
    Recruiting
  • University Hospital, Toulouse
    Toulouse, France
    • Françoise Huguet, MD · Sub investigator
    Recruiting
  • Versailles Hospital
    Versailles, France
    • Philippe Rousselot, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Saugues S, Lambert C, Daguenet E, Ansah HJ, Turhan A, Huguet F, Guerci-Bresler A, Tchirkov A, Hamroun D, Hermet E, Pereira B, Berger MG. Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukemia: data from the French observatory. Ann Hematol. 2022 Oct;101(10):2241-2255. doi: 10.1007/s00277-022-04955-z. Epub 2022 Aug 30. PubMed 36040480 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05963061
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre Hospitalier Universitaire de Saint Etienne, Bicetre Hospital, University Hospital, Caen, Central Hospital, Nancy, France, University Hospital, Toulouse, CH Annecy Genevois, Rennes University Hospital, Hopital Paul Brousse, Versailles Hospital, Centre Hospitalier Emile Roux, University Hospital, Limoges, Institut Paoli-Calmettes, Centre Hospitalier de Rochefort
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Apr 16, 2014
Primary completion
Apr 16, 2034 (estimated)
Completion
Apr 16, 2034 (estimated)
Last update
Apr 9, 2024

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
04 73 75 11 95
Marc BERGER, MD
study director · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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