Leukemia, Lymphocytic, Chronic, B-CellFIRENCT03425591
A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Mantle-Cell, run by Janssen-Cilag Ltd. at 1 site in France.
Trial summary
The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
- What is being tested?
- Ibrutinib
- How many people
- 508 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2016to 11 Aug 2022
- 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: Study population include chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma (MCL) participants who were or will be treated by ibrutinib per routine clinical care on or after 21 November 2014.
Who may be able to join
- Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:
- treatment of CLL/SLL in participants who have received at least 1 prior therapy; or
- treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or
- treatment of participants with relapsed or refractory MCL
- Not currently participating in another investigational study, clinical study, or any expanded access program at study entry
- Has not participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
- Participant must sign a written informed consent form (ICF) allowing data collection and source data verification
Who cannot join
- Currently participating in another investigational study, clinical study, or any expanded access program at study entry
- Participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).
- Being tested
- Ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib in routine clinical practice settings will be observed for 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants | Participants with confirmed diagnosis of CLL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 1. The primary data source for this observational study will be the medical records of each enrolled participant. Receives: Drug: Ibrutinib | |
| Cohort 2: Mantle-Cell Lymphoma (MCL) Participants | Participants with confirmed diagnosis of MCL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 2. The primary data source for this observational study will be the medical records of each enrolled participant. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive-Free Survival (PFS)
PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir.
Measured: Approximately up to 5 years
Secondary outcomes (11)
Overall Response Rate (ORR)
ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician.
Measured: Approximately up to 5 years
Time to First Response
Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response.
Measured: Approximately up to 5 years
Time to Best Response
Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response.
Measured: Approximately up to 5 years
Duration of Response
Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by >=50% of previously involved sites from nadir.
Measured: Approximately up to 5 years
Overall survival (OS)
Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death.
Measured: Approximately up to 5 years
Duration of Ibrutinib Therapy
Duration of ibrutinib therapy in CLL and MCL participants will be reported.
Measured: Approximately up to 5 years
Duration of a Treatment-Free Period
Duration of treatment-free period in CLL and MCL participants will be reported.
Measured: Every 6 months (Approximately up to 5 years)
Duration of the First Non-Ibrutinib Subsequent Therapy Period
Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported.
Measured: Approximately up to 5 years
Participants' Daily Dose
Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed.
Measured: Approximately up to 5 years
Number of Participants Who Require Dose Modifications
Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported.
Measured: Approximately up to 5 years
Number of Medications Added
Number of medications added in the CLL and MCL treatment will be reported.
Measured: Approximately up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start11 May 2016
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies 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
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425591
- Sponsor's protocol ID
- CR107363
- Other IDs
- 54179060CAN4001
- Acronym
- FIRE
- Status last verified
- Oct 2022
- First submitted
- 1 Feb 2018
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dartigeas C, Quinquenel A, Ysebaert L, Dilhuydy MS, Anglaret B, Slama B, Le Du K, Tardy S, Tchernonog E, Orfeuvre H, Voillat L, Guidez S, Malfuson JV, Dupuis S, Deslandes M, Feugier P, Leblond V; FIRE Investigators Group. Final results on effectiveness and safety of Ibrutinib in patients with chronic lymphocytic leukemia from the non-interventional FIRE study. Ann Hematol. 2025 Feb;104(2):1079-1093. doi: 10.1007/s00277-024-05666-3. Epub 2024 Mar 6.
PubMed 38443660Dartigeas C, Slama B, Doyle M, Tapprich C, Albrecht C, Dupuis S, Wapenaar R, Schmidt-Hieber C, Leblond V. FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL. Clin Hematol Int. 2022 Sep;4(3):65-74. doi: 10.1007/s44228-022-00015-5. Epub 2022 Sep 14.
PubMed 36103041
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03425591
- Acronym / sponsor ID
- FIRE / CR107363
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 7 Feb 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.
The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants | – | Drug: IbrutinibParticipants with confirmed diagnosis of CLL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 1. The primary data source for this observational study will be the medical records of each enrolled participant. |
| Cohort 2: Mantle-Cell Lymphoma (MCL) Participants | – | Drug: IbrutinibParticipants with confirmed diagnosis of MCL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 2. The primary data source for this observational study will be the medical records of each enrolled participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population include chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma (MCL) participants who were or will be treated by ibrutinib per routine clinical care on or after 21 November 2014.
Key inclusion criteria (7 listed)
- Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:
- Not currently participating in another investigational study, clinical study, or any expanded access program at study entry
- Has not participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
- Participant must sign a written informed consent form (ICF) allowing data collection and source data verification
Key exclusion criteria (2 listed)
- Currently participating in another investigational study, clinical study, or any expanded access program at study entry
- Participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibParticipants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib in routine clinical practice settings will be observed for 5 years. | Drug | Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants, Cohort 2: Mantle-Cell Lymphoma (MCL) Participants |
Primary outcome
Progressive-Free Survival (PFS)
Time frame: Approximately up to 5 years
PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir.
11 secondary outcomes
Overall Response Rate (ORR)
Time frame: Approximately up to 5 years
Time to First Response
Time frame: Approximately up to 5 years
Time to Best Response
Time frame: Approximately up to 5 years
Duration of Response
Time frame: Approximately up to 5 years
Overall survival (OS)
Time frame: Approximately up to 5 years
Duration of Ibrutinib Therapy
Time frame: Approximately up to 5 years
Duration of a Treatment-Free Period
Time frame: Every 6 months (Approximately up to 5 years)
Duration of the First Non-Ibrutinib Subsequent Therapy Period
Time frame: Approximately up to 5 years
Participants' Daily Dose
Time frame: Approximately up to 5 years
Number of Participants Who Require Dose Modifications
Time frame: Approximately up to 5 years
Number of Medications Added
Time frame: Approximately up to 5 years
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 6 Oct 2022.
- Derived from this study: PubMed 38443660Dartigeas C, Quinquenel A, Ysebaert L, Dilhuydy MS, Anglaret B, Slama B, Le Du K, Tardy S, Tchernonog E, Orfeuvre H, Voillat L, Guidez S, Malfuson JV, Dupuis S, Deslandes M, Feugier P, Leblond V; FIRE Investigators Group. Final results on effectiveness and safety of Ibrutinib in patients with chronic lymphocytic leukemia from the non-interventional FIRE study. Ann Hematol. 2025 Feb;104(2):1079-1093. doi: 10.1007/s00277-024-05666-3. Epub 2024 Mar 6.
- Derived from this study: PubMed 36103041Dartigeas C, Slama B, Doyle M, Tapprich C, Albrecht C, Dupuis S, Wapenaar R, Schmidt-Hieber C, Leblond V. FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL. Clin Hematol Int. 2022 Sep;4(3):65-74. doi: 10.1007/s44228-022-00015-5. Epub 2022 Sep 14.
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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.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Mantle-Cell, run by Janssen-Cilag Ltd. at 1 site 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 7 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Progressive-Free Survival (PFS) (time frame: Approximately up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425591, which also lists 2 linked publications.
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 6 Oct 2022.