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

NCT ID: NCT03502876

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-02

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Observationnal and biological study

Conditions

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B Cell Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence CYMBALISTA, MD PD

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organization

Locations

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FILO French Innovative Leukemia Organization

Tours, , France

Site Status

Project manager

Tours, , France

Site Status

Countries

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France

Related Links

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Other Identifiers

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RESISTANCE A L'IBRUTINIB

Identifier Type: -

Identifier Source: org_study_id

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