NCT05963061

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
97mo left

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Apr 2014Apr 2034

Study Start

First participant enrolled

April 16, 2014

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2034

Last Updated

April 9, 2024

Status Verified

February 1, 2024

Enrollment Period

20 years

First QC Date

February 20, 2023

Last Update Submit

April 5, 2024

Conditions

Chronic Myeloid Leukemia (CML)

Keywords

LeukemiaLeukemia, MyeloidChronic myeloid leukemiaChronic, BCR::ABL PositiveHematologic MalignanciesTyrosine kinase inhibitor (TKI)Targeted therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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)

  • +6 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with a diagnose of CML

You may qualify if:

  • Patient diagnosed for chronic myelocytic leukemia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

CH Annecy Genevois

Annecy, France

RECRUITING

University Hospital, Caen

Caen, France

RECRUITING

CHU Clemront-Ferrand

Clermont-Ferrand, France

RECRUITING

Centre Hospitalier Emile Roux

Le Puy-en-Velay, France

RECRUITING

University Hospital, Limoges

Limoges, France

RECRUITING

Institut Paoli-Calmettes

Marseille, France

RECRUITING

Centre Hospital, Nancy

Nancy, France

RECRUITING

Bicetre Hospital

Paris, France

RECRUITING

Hopital Paul Brousse

Paris, France

RECRUITING

Rennes University Hospital

Rennes, France

RECRUITING

Centre Hospitalier de Rochefort

Rochefort, France

RECRUITING

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, France

RECRUITING

University Hospital, Toulouse

Toulouse, France

RECRUITING

Versailles Hospital

Versailles, France

RECRUITING

Related 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 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.

    PMID: 36040480RESULT

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemiaLeukemia, MyeloidBronchiolitis Obliterans SyndromeHematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesNeoplasms by Site

Study Officials

  • Marc BERGER, MD

    University Hospital, Clermont-Ferrand

    STUDY DIRECTOR

Central Study Contacts

Lise Laclautre

CONTACT

04 73 75 11 95promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

July 27, 2023

Study Start

April 16, 2014

Primary Completion (Estimated)

April 16, 2034

Study Completion (Estimated)

April 16, 2034

Last Updated

April 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(14)