Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05963061

Chronic Myeloid Leukemia (CML) Real-Life Database

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Myeloid Leukemia (CML) Bone Marrow Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Graft vs Host Disease Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Lung Diseases Lung Diseases, Obstructive Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Annecy Genevois, Annecy, France

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient diagnosed for chronic myelocytic leukemia

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Clinical and biological data collection

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

    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).

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)

Study contacts

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

Lise Laclautre

CONTACT

[email protected]

04 73 75 11 95

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Bicetre Hospital
  • CH Annecy Genevois
  • Central Hospital, Nancy, France
  • Centre Hospitalier Emile Roux
  • Centre Hospitalier Universitaire de Saint Etienne
  • Centre Hospitalier de Rochefort
  • Hopital Paul Brousse
  • Institut Paoli-Calmettes
  • Rennes University Hospital
  • University Hospital, Caen
  • University Hospital, Limoges
  • University Hospital, Toulouse
  • Versailles Hospital

Registry information

Important dates

Study start
2014
Primary completion
2034
Study completion
2034
First posted
Jul 27, 2023
Registry last updated
Apr 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.