Clinical trial · Observational
A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
NCT03425591CI-TRIAL-00061273FIREcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants
- description
- 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.
- interventionNames
- Drug: Ibrutinib
- label
- Cohort 2: Mantle-Cell Lymphoma (MCL) Participants
- description
- 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.
- interventionNames
- Drug: Ibrutinib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or 3. 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 Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDDartigeas 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. PMID 38443660
- DERIVEDDartigeas 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. PMID 36103041