Chronic Myeloid Leukemia (CML) Real-Life Database

Recruiting

• Conditions: Chronic Myeloid Leukemia (CML)

• Registration Number: NCT05963061
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

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 Timeline

• Study Start: 2014-04-16
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09
• Primary Completion: 2034-04-16
• Study Completion: 2034-04-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

• Patient diagnosed for chronic myelocytic leukemia

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and biological data collection	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 Outcome Measures

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

Trial Locations

Locations (14)

CH Annecy Genevois; 🇫🇷 Annecy, France

University Hospital, Caen; 🇫🇷 Caen, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Centre Hospitalier Emile Roux; 🇫🇷 Le Puy-en-Velay, France

Rennes University Hospital; 🇫🇷 Rennes, France

Bicetre Hospital; 🇫🇷 Paris, France

Hopital Paul Brousse; 🇫🇷 Paris, France

University Hospital, Toulouse; 🇫🇷 Toulouse, France

Versailles Hospital; 🇫🇷 Versailles, France

CHU Clemront-Ferrand; 🇫🇷 Clermont-Ferrand, France

University Hospital, Limoges; 🇫🇷 Limoges, France

Centre Hospital, Nancy; 🇫🇷 Nancy, France

Centre Hospitalier Universitaire de Saint Etienne; 🇫🇷 Saint-Étienne, France

Centre Hospitalier de Rochefort; 🇫🇷 Rochefort, France