NCT03502876

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

November 2, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

April 11, 2018

Last Update Submit

May 15, 2020

Conditions

B Cell Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Ibrutinib resistance

    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.

    under treatment at 3 years of ibrutinib

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with CLL and treated by ibrutinib in the ATU

You may qualify if:

  • patients included in the ATU (epidemiology)
  • under treatment at 3 years of ibrutinib
  • more than 18 years old

You may not qualify if:

  • no ibrutinib treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FILO French Innovative Leukemia Organization

Tours, 37044, France

Location

Project manager

Tours, 37044, France

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

collection of a blood sample

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Florence CYMBALISTA, MD PD

    French Innovative Leukemia Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 19, 2018

Study Start

November 2, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)