Chronic Myeloid Leukemia (CML)
Conditions
Keywords
Leukemia, Leukemia, Myeloid, Chronic myeloid leukemia, Chronic, BCR::ABL Positive, Hematologic Malignancies, Tyrosine kinase inhibitor (TKI), Targeted therapy
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).
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Bicetre Hospital
University Hospital, Caen
Central Hospital, Nancy, France
University Hospital, Toulouse
CH Annecy Genevois
Rennes University Hospital
Hopital Paul Brousse
Versailles Hospital
Centre Hospitalier Emile Roux
University Hospital, Limoges
Institut Paoli-Calmettes
Centre Hospitalier de Rochefort
University Hospital, Clermont-Ferrand
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| BMI with evaluation of weight and height | 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 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 molecular response MR5 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 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) |
| Evaluation of cytogenetic response | Until death or last follow up (up to 30 years) |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed