Tolerance and Resistance to Ibrutinib in Patients With Ch... | NCT03502876

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

NCT03502876

Sponsor

French Innovative Leukemia Organisation

Status

Completed

Last Update Posted

May 18, 2020Actual

Enrollment

198Actual

Phase

Not provided

Conditions

B Cell Chronic Lymphocytic Leukemia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Apr 11, 2018

First Submission Date that Met QC Criteria

Apr 11, 2018

First Posted Date

Apr 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2020

Last Update Posted Date

May 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Observationnal and biological study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

198Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with CLL and treated by ibrutinib in the ATU

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florence CYMBALISTA, MD PD	French Innovative Leukemia Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FILO French Innovative Leukemia Organization		Tours		37044	France
Project manager

Label	URL
FILO internet site	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided