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Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL

Sponsor
French Innovative Leukemia Organisation (Other)
Overall Status
Completed
CT.gov ID
NCT03502876
Collaborator
(none)
198
Enrollment
2
Locations
25.9
Actual Duration (Months)
99
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib

This project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of BTK mutations and PLCg2 in the absence of clinical or biological criteria for scalability.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Observationnal and biological study

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    198 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL): Analysis of Real-life Data: "Snapshot" at 3 Years From the End of Ibrutinib ATU. A National Study of the FILO-LLC Group
    Actual Study Start Date :
    Nov 2, 2017
    Actual Primary Completion Date :
    Dec 31, 2018
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Ibrutinib resistance [under treatment at 3 years of ibrutinib]

      In the long term, this study will help to draft new recommendations from FILO-LLC concerning the detection of resistance and the management of patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • patients included in the ATU (epidemiology)

    • under treatment at 3 years of ibrutinib

    • more than 18 years old

    Exclusion Criteria:
    • no ibrutinib treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 FILO French Innovative Leukemia Organization Tours France 37044
    2 Project manager Tours France 37044

    Sponsors and Collaborators

    • French Innovative Leukemia Organisation

    Investigators

    • Principal Investigator: Florence CYMBALISTA, MD PD, French Innovative Leukemia Organization

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    French Innovative Leukemia Organisation
    ClinicalTrials.gov Identifier:
    NCT03502876
    Other Study ID Numbers:
    • RESISTANCE A L'IBRUTINIB
    First Posted:
    Apr 19, 2018
    Last Update Posted:
    May 18, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of May 18, 2020