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NCT05963061 Clinical Trial

Chronic Myeloid Leukemia (CML) Real-Life Database

Chronic Myeloid Leukemia (CML) Clinical Trial

Official title:
Chronic Myeloid Leukemia (CML) Real-Life Database

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05963061
Other study ID # CML Observatory
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 16, 2014
Est. completion date April 16, 2034

Study information
Verified date February 2024
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 04 73 75 11 95
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 3500
Est. completion date April 16, 2034
Est. primary completion date April 16, 2034
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patient diagnosed for chronic myelocytic leukemia Exclusion Criteria: - CML allograft without TKI treatment - Refusal or inability to sign the consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CH Annecy Genevois Annecy
France University Hospital, Caen Caen
France CHU Clemront-Ferrand Clermont-Ferrand
France Centre Hospitalier Emile Roux Le Puy-en-Velay
France University Hospital, Limoges Limoges
France Institut Paoli-Calmettes Marseille
France Centre Hospital, Nancy Nancy
France Bicetre Hospital Paris
France Hopital Paul Brousse Paris
France Rennes University Hospital Rennes
France Centre Hospitalier de Rochefort Rochefort
France Centre Hospitalier Universitaire de Saint Etienne Saint-Étienne
France University Hospital, Toulouse Toulouse
France Versailles Hospital Versailles

Sponsors (14)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Bicetre Hospital, Central Hospital, Nancy, France, Centre Hospitalier de Rochefort, Centre Hospitalier Emile Roux, Centre Hospitalier Universitaire de Saint Etienne, CH Annecy Genevois, Hopital Paul Brousse, Institut Paoli-Calmettes, Rennes University Hospital, University Hospital, Caen, University Hospital, Limoges, University Hospital, Toulouse, Versailles Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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 leukemi — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical and biological data collection 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). Until death or last follow up (up to 30 years)
Secondary Prognosis score for CML (Sokal, ELTS, Eutos, Hasford) At diagnosis
Secondary BMI with evaluation of weight and height Until death or last follow up (up to 30 years)
Secondary Evaluation of major molecular response (MMR) with transcript BCR::ABL in % Until death or last follow up (up to 30 years)
Secondary Evaluation of molecular response MR4 with transcript BCR::ABL in % Until death or last follow up (up to 30 years)
Secondary Evaluation of molecular response MR4.5 with transcript BCR::ABL in % Until death or last follow up (up to 30 years)
Secondary Evaluation of molecular response MR5 with transcript BCR::ABL in % Until death or last follow up (up to 30 years)
Secondary Evaluation of cytogenetic response Until death or last follow up (up to 30 years)
Secondary Evaluation of TKI efficacy based on transcript BCR::ABL in % Until death or last follow up (up to 30 years)
Secondary Evaluation of TKI tolerance (adverses events) Until death or last follow up (up to 30 years)
Secondary 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)
Secondary Listing of major medical history of patient's CML Until death or last follow up (up to 30 years)
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Completed NCT01667133 - A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) Phase 1/Phase 2
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