Clinical trial NCT05963061: Chronic Myeloid Leukemia (CML) Real-Life Database
Official title: Chronic Myeloid Leukemia (CML) Real-Life Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Myeloid Leukemia (CML)
Keywords: Leukemia
Leukemia, Myeloid
Chronic myeloid leukemia
Chronic, BCR::ABL Positive
Hematologic Malignancies
Tyrosine kinase inhibitor (TKI)
Targeted therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Saint Etienne
name: Bicetre Hospital
name: University Hospital, Caen
name: Central Hospital, Nancy, France
name: University Hospital, Toulouse
name: CH Annecy Genevois
name: Rennes University Hospital
name: Hopital Paul Brousse
name: Versailles Hospital
name: Centre Hospitalier Emile Roux
name: University Hospital, Limoges
name: Institut Paoli-Calmettes
name: Centre Hospitalier de Rochefort
First posted: 2023-07-27
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with a diagnose of CML

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).

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed for chronic myelocytic leukemia

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical and biological data collection
timeFrame: Until death or last follow up (up to 30 years)
Secondary outcomes:
measure: Prognosis score for CML (Sokal, ELTS, Eutos, Hasford)
timeFrame: At diagnosis
measure: BMI with evaluation of weight and height
timeFrame: Until death or last follow up (up to 30 years)
measure: Evaluation of major molecular response (MMR) with transcript BCR::ABL in %
timeFrame: Until death or last follow up (up to 30 years)
measure: Evaluation of molecular response MR4 with transcript BCR::ABL in %
timeFrame: Until death or last follow up (up to 30 years)
measure: Evaluation of molecular response MR4.5 with transcript BCR::ABL in %
timeFrame: Until death or last follow up (up to 30 years)
measure: Evaluation of molecular response MR5 with transcript BCR::ABL in %
timeFrame: Until death or last follow up (up to 30 years)
measure: Evaluation of cytogenetic response
timeFrame: Until death or last follow up (up to 30 years)
measure: Evaluation of TKI efficacy based on transcript BCR::ABL in %
timeFrame: Until death or last follow up (up to 30 years)
measure: Evaluation of TKI tolerance (adverses events)
timeFrame: Until death or last follow up (up to 30 years)
measure: Calcul in month of the duration of maintenance TFR (treatment free remission) after stop TKI for thérapeutic response
timeFrame: Until death or last follow up (up to 30 years)
measure: Listing of major medical history of patient's CML
timeFrame: Until death or last follow up (up to 30 years)
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH Annecy Genevois
city: Caen
country: France
facility: University Hospital, Caen
city: Clermont-Ferrand
country: France
facility: CHU Clemront-Ferrand
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Limoges
country: France
facility: University Hospital, Limoges
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nancy
country: France
facility: Centre Hospital, Nancy
city: Paris
country: France
facility: Bicetre Hospital
city: Paris
country: France
facility: Hopital Paul Brousse
city: Rennes
country: France
facility: Rennes University Hospital
city: Rochefort
country: France
facility: Centre Hospitalier de Rochefort
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
city: Toulouse
country: France
facility: University Hospital, Toulouse
city: Versailles
country: France
facility: Versailles Hospital
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marc BERGER, MD
role: STUDY_DIRECTOR
References:
citation: 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.