Chronic Myeloid Leukemia (CML) Real-Life Database

April 5, 2024 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Recruiting

Conditions

Chronic Myeloid Leukemia (CML)

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).

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lise Laclautre
Phone Number: 04 73 75 11 95
Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Any patient with a diagnose of CML

Description

Inclusion Criteria:

Patient diagnosed for chronic myelocytic leukemia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Until death or last follow up (up to 30 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Prognosis score for CML (Sokal, ELTS, Eutos, Hasford) Time Frame: At diagnosis	At diagnosis
BMI with evaluation of weight and height Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
Evaluation of major molecular response (MMR) with transcript BCR::ABL in % Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
Evaluation of molecular response MR4 with transcript BCR::ABL in % Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
Evaluation of molecular response MR4.5 with transcript BCR::ABL in % Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
Evaluation of molecular response MR5 with transcript BCR::ABL in % Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
Evaluation of cytogenetic response Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
Evaluation of TKI efficacy based on transcript BCR::ABL in % Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
Evaluation of TKI tolerance (adverses events) Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)
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)	Until death or last follow up (up to 30 years)
Listing of major medical history of patient's CML Time Frame: Until death or last follow up (up to 30 years)	Until death or last follow up (up to 30 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Central Hospital, Nancy, France

University Hospital, Caen

University Hospital, Limoges

Versailles Hospital

Rennes University Hospital

University Hospital, Toulouse

Institut Paoli-Calmettes

Bicetre Hospital

Centre Hospitalier Emile Roux

CH Annecy Genevois

Centre Hospitalier de Rochefort

Hopital Paul Brousse

Investigators

Study Director: Marc BERGER, MD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukaemia: Data from the French observatory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2014

Primary Completion (Estimated)

April 16, 2034

Study Completion (Estimated)

April 16, 2034

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CML Observatory

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.