B Cell Chronic Lymphocytic LeukemiaNCT03502876
Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL
An observational study of B Cell Chronic Lymphocytic Leukemia, run by French Innovative Leukemia Organisation at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Chronic Lymphocytic Leukemia
- How many people
- 198 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Nov 2017to 31 Dec 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with CLL and treated by ibrutinib in the ATU
Who may be able to join
- patients included in the ATU (epidemiology)
- under treatment at 3 years of ibrutinib
- more than 18 years old
Who cannot join
- no ibrutinib treatment
Trial locations and contacts
2 sites in 1 country.
France2 sites
FILO French Innovative Leukemia Organization
Tours, 37044
Project manager
Tours, 37044
About this study
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
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.
Read the detailed description
Observationnal and biological study
- Conditions
- B Cell Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: under treatment at 3 years of ibrutinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start2 Nov 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence CYMBALISTA, MD PD, Principal investigator, French Innovative Leukemia Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502876
- Sponsor's protocol ID
- RESISTANCE A L'IBRUTINIB
- Status last verified
- May 2020
- First submitted
- 11 Apr 2018
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03502876
- Acronym / sponsor ID
- RESISTANCE A L'IBRUTINIB
- Conditions
- B Cell Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with CLL and treated by ibrutinib in the ATU
Key inclusion criteria (3 listed)
- patients included in the ATU (epidemiology)
- under treatment at 3 years of ibrutinib
- more than 18 years old
Key exclusion criteria (1 listed)
- no ibrutinib treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ibrutinib resistance
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- FILO internet siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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HPC Offered for PRESERVE Expansion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence CYMBALISTA, MD PD principal investigator
French Innovative Leukemia Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B Cell Chronic Lymphocytic Leukemia, run by French Innovative Leukemia Organisation at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ibrutinib resistance (time frame: under treatment at 3 years of ibrutinib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.