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Chronic Myeloid Leukemia (CML)NCT05963061

Chronic Myeloid Leukemia (CML) Real-Life Database

An observational study of Chronic Myeloid Leukemia (CML), run by University Hospital, Clermont-Ferrand at 14 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

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Chronic Myeloid Leukemia (CML)
How many people
3,500 participants
Where
14 sitesFrance
Study dates
16 Apr 2014to 16 Apr 2034
How long will I take part?
30 Years
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Any patient with a diagnose of CML

Who may be able to join

  • Patient diagnosed for chronic myelocytic leukemia

Who cannot join

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

Trial locations and contacts

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

Lise Laclautre contact

04 73 75 11 95

promo_interne_drci@chu-clermontferrand.fr

14 sites in 1 country

France14 sites, 14 recruiting

  • CH Annecy Genevois

    Annecy

    Anne Parry, MD

    Recruiting

  • University Hospital, Caen

    Caen

    Atchroue Johnson Ansah, MD

    Recruiting

  • CHU Clemront-Ferrand

    Clermont-Ferrand

    Marc Berger, MD

    Recruiting

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay

    Vanessa Pante, MD

    Recruiting

  • University Hospital, Limoges

    Limoges

    Amelie Penot, MD

    Recruiting

  • Institut Paoli-Calmettes

    Marseille

    Aude CHARBONNIER, MD

    Recruiting

  • Centre Hospital, Nancy

    Nancy

    Agnès Guerci-Bresler, MD

    Recruiting

  • Bicetre Hospital

    Paris

    Ali Turhan, MD

    Recruiting

  • Hopital Paul Brousse

    Paris

    Laurence Legros, MD

    Recruiting

  • Rennes University Hospital

    Rennes

    Martine Escoffre-Barbe, MD

    Recruiting

  • Centre Hospitalier de Rochefort

    Rochefort

    Guillaume DENIS, MD

    Recruiting

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Etienne

    Denis Guyotat, MD

    Recruiting

  • University Hospital, Toulouse

    Toulouse

    Françoise Huguet, MD

    Recruiting

  • Versailles Hospital

    Versailles

    Philippe Rousselot, MD

    Recruiting

Other trials in France

About this study

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).

Keywords
Leukemia, Leukemia, Myeloid, Chronic myeloid leukemia, Chronic, BCR::ABL Positive, Hematologic Malignancies, Tyrosine kinase inhibitor (TKI), Targeted therapy
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Leukemia, Myeloid, Bronchiolitis Obliterans Syndrome, Hematologic Neoplasms

What is being measured

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

  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).

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

Secondary outcomes (11)

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

    Measured: At diagnosis

  2. BMI with evaluation of weight and height

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

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

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

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

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

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

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

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

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

  7. Evaluation of cytogenetic response

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

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

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

  9. Evaluation of TKI tolerance (adverses events)

    Measured: 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

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

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

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

Timeline

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

  1. First posted27 Jul 2023
  2. Study start16 Apr 2014
  3. Primary completion16 Apr 2034 (estimated)
  4. Study completion16 Apr 2034 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,500 participants (estimated)
Target duration
30 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963061
Sponsor's protocol ID
CML Observatory
Status last verified
Feb 2024
First submitted
20 Feb 2023
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Myeloid Leukemia (CML), run by University Hospital, Clermont-Ferrand at 14 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 1 inclusion and 2 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 (04 73 75 11 95, 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?

Clinical and biological data collection (time frame: Until death or last follow up (up to 30 years)). 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 NCT05963061, 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 9 Apr 2024.

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