Chronic Myeloid Leukemia (CML) Real-Life Database

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT05963061

Collaborator

Centre Hospitalier Universitaire de Saint Etienne (Other), Bicetre Hospital (Other), University Hospital, Caen (Other), Central Hospital, Nancy, France (Other), University Hospital, Toulouse (Other), CH Annecy Genevois (Other), Rennes University Hospital (Other), Hopital Paul Brousse (Other), Versailles Hospital (Other), Centre Hospitalier Emile Roux (Other), University Hospital, Limoges (Other)

3,500

Enrollment

Locations

240

Anticipated Duration (Months)

291.7

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3500 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Chronic Myeloid Leukemia (CML) Real-Life Database

Actual Study Start Date :

Apr 16, 2014

Anticipated Primary Completion Date :

Apr 16, 2034

Anticipated Study Completion Date :

Apr 16, 2034

Outcome Measures

Primary Outcome Measures

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

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 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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient diagnosed for chronic myelocytic leukemia

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country
1	CH Annecy Genevois	Annecy	France
2	University Hospital, Caen	Caen	France
3	CHU Clemront-Ferrand	Clermont-Ferrand	France
4	Centre Hospitalier Emile Roux	Le Puy-en-Velay	France
5	University Hospital, Limoges	Limoges	France
6	Centre Hospital, Nancy	Nancy	France
7	Bicetre Hospital	Paris	France
8	Hopital Paul Brousse	Paris	France
9	Rennes University Hospital	Rennes	France
10	Centre Hospitalier Universitaire de Saint Etienne	Saint-Étienne	France
11	University Hospital, Toulouse	Toulouse	France
12	Versailles Hospital	Versailles	France