CLL, RelapsedRESISTNCT05621148
REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy
An observational study of CLL, Relapsed and CLL, Refractory, run by French Innovative Leukemia Organisation at 8 sites in France.
Trial summary
Data evaluating and quantifying real-world outcomes of patients post-ibrutinib discontinuation, as well as outcomes of patients who have progressed on a Bruton tyrosine kinases inhibitors (BTKi) and received prior venetoclax are very limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL, Relapsed, CLL, Refractory, Bruton Tyrosine Kinase Inhibitor
- How many people
- 152 participants
- Where
- 8 sitesFrance
- Study dates
- 25 Jan 2023to 31 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients previously exposed to ibrutinib (or other BTKi) : treatment with a BTKi in at least one of two or more prior lines of therapy and progressed
Who may be able to join
- Documented diagnosis of CLL or small lymphocytic leukemia (SLL).
- ≥ 18 years of age the time of initial diagnosis.
- Venetoclax therapy in at least third line of treatment (LOT) during the period considered, following at least one LOT with BTKi
- Patients who received VEN during prior LOTs are eligible.
- Patient not opposed to data collection (including deceased patients)
Who cannot join
- Exposure to cellular therapy, including CAR T-cells / Allo-Stem Cell Transplantation.
- Richter's transformation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Estaing - Hématologie Clinique Adulte
Clermont-Ferrand, 63000
Centre Léon Bérard - Hématologie
Lyon, 69373
Institut Paoli-Calmettes - Hématologie Clinique
Marseille, 13273
MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique
Montpellier, 34295
Bordeaux Pessac
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Strasbourg - Icans
Strasbourg, 67033
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse, 31059
About this study
Official title: REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy. A FILO Study.
Data evaluating and quantifying real-world outcomes of patients post-ibrutinib discontinuation, as well as outcomes of patients who have progressed on a Bruton tyrosine kinases inhibitors (BTKi) and received prior venetoclax are very limited. There are no robust studies specifically designed to assess outcomes of patients with chronic lymphocytic leukemia (CLL) receiving third line or subsequent treatments. As such, there is no established standard of care for these multiple Relapsed/Refractory (RR) patients. Furthermore, despite new oral agents approved in third-line RR CLL, there are limited published data on how to best sequence these agents and how to manage patients who fail these therapies. As the best salvage therapy in patients who fail all available oral these agents is unknown, this is a population of patients with unmet medical need.
The aim of this study is to determine unmet need and treatment patterns of data from two types of populations, all previously exposed to ibrutinib (or other BTKi) for the full patient population and both ibrutinib (or other BTKi and venetoclax) for the narrow patient population, where these agents failed these subcategories of patient populations, at least in 3rd line therapy (in other words, having at least received two lines of therapy before)
- Patients with prior treatment with BTKi (full patient population) - Underlying tenet: these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION
- Patients who progressed BTKi and failed VEN (defined as patients who discontinued venetoclax (VEN) due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed. - NARROW POPULATION
- Conditions
- CLL, Relapsed, CLL, Refractory, Bruton Tyrosine Kinase Inhibitor, Small Lymphocytic Leukemia
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Full population | LLC patients with prior treatment with BTKi - Underlying tenet: these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION | |
| Narrow population | LLC Patients who progressed BTKi and failed VEN (defined as patients who discontinued VEN due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of treatment patterns in patients with CLL
Overall response rate (complete, partial, stable) for each treatment received
Measured: from BTKi initiation until progression/failure at Venetoclax treatment, assessed up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start25 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL, RelapsedStudies 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
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Loïc YSEBAERT, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621148
- Sponsor's protocol ID
- FILObsLLC_RESIST
- Acronym
- RESIST
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy. A FILO Study.
- ClinicalTrials.gov ID
- NCT05621148
- Acronym / sponsor ID
- RESIST / FILObsLLC_RESIST
- Conditions
- CLL, Relapsed, CLL, Refractory, Bruton Tyrosine Kinase Inhibitor, Small Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 17 Nov 2022 (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.
Data evaluating and quantifying real-world outcomes of patients post-ibrutinib discontinuation, as well as outcomes of patients who have progressed on a Bruton tyrosine kinases inhibitors (BTKi) and received prior venetoclax are very limited. There are no robust studies specifically designed to assess outcomes of patients with chronic lymphocytic leukemia (CLL) receiving third line or subsequent treatments. As such, there is no established standard of care for these multiple Relapsed/Refractory (RR) patients. Furthermore, despite new oral agents approved in third-line RR CLL, there are limited published data on how to best sequence these agents and how to manage patients who fail these therapies. As the best salvage therapy in patients who fail all available oral these agents is unknown, this is a population of patients with unmet medical need.
The aim of this study is to determine unmet need and treatment patterns of data from two types of populations, all previously exposed to ibrutinib (or other BTKi) for the full patient population and both ibrutinib (or other BTKi and venetoclax) for the narrow patient population, where these agents failed these subcategories of patient populations, at least in 3rd line therapy (in other words, having at least received two lines of therapy before)
- Patients with prior treatment with BTKi (full patient population) - Underlying tenet: these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION
- Patients who progressed BTKi and failed VEN (defined as patients who discontinued venetoclax (VEN) due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed. - NARROW POPULATION
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full population | – | –LLC patients with prior treatment with BTKi - Underlying tenet: these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION |
| Narrow population | – | –LLC Patients who progressed BTKi and failed VEN (defined as patients who discontinued VEN due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients previously exposed to ibrutinib (or other BTKi) : treatment with a BTKi in at least one of two or more prior lines of therapy and progressed
Key inclusion criteria (5 listed)
- Documented diagnosis of CLL or small lymphocytic leukemia (SLL).
- ≥ 18 years of age the time of initial diagnosis.
- Venetoclax therapy in at least third line of treatment (LOT) during the period considered, following at least one LOT with BTKi
- Patients who received VEN during prior LOTs are eligible.
- Patient not opposed to data collection (including deceased patients)
Key exclusion criteria (2 listed)
- Exposure to cellular therapy, including CAR T-cells / Allo-Stem Cell Transplantation.
- Richter's transformation.
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
Response rate of treatment patterns in patients with CLL
Time frame: from BTKi initiation until progression/failure at Venetoclax treatment, assessed up to 7 years
Overall response rate (complete, partial, stable) for each treatment received
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 3 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Loïc YSEBAERT principal investigator
French Innovative Leukemia Organisation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLL, Relapsed and CLL, Refractory, run by French Innovative Leukemia Organisation at 8 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 5 inclusion and 2 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Response rate of treatment patterns in patients with CLL (time frame: from BTKi initiation until progression/failure at Venetoclax treatment, assessed up to 7 years). 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 3 Dec 2025.