Chronic Myeloid Leukemia (CML) Real-Life Database
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,500
- Locations
- 14
- Primary Endpoint
- Clinical and biological data collection
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient diagnosed for chronic myelocytic leukemia
Exclusion Criteria
- •CML allograft without TKI treatment
- •Refusal or inability to sign the consent
Outcomes
Primary Outcomes
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
- Prognosis score for CML (Sokal, ELTS, Eutos, Hasford)(At diagnosis)
- 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))
- 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))