Clinical trial · Observational
Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib
Real Life Assessment of the Association and Its Determinants Between Side Effects and Plasmatic Concentrations of Two Protein Kinase Inhibitors: Ibrutinib (IMBRUVICA®) and Idelalisib (ZYDELIG®) in Hematological Malignancies Treatment.
- 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)
Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological statement | Other | — | UNRESOLVED |
| Blood sample | Genetic | — | UNRESOLVED |
| Blood samples for pharmacokinetics exploration | Other | — | UNRESOLVED |
| Clinical examination | Other | — | UNRESOLVED |
| Detection of adverse events | Other | — | UNRESOLVED |
| Imagery | Other | — | UNRESOLVED |
| Quality of life scale | Other | — | UNRESOLVED |
| Saliva samples | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient with haematologic malignancies
- description
- Interventions to be administrated are : * Clinical examinations * Biological statement * Blood samples for pharmacokinetics exploration * Imagery with positron emission tomography scan or resonance magnetic imagery * Saliva samples for genetics analyses * Blood samples for treatment mutation resistance search * Quality of life scale questionary * Detection of adverse events
- interventionNames
- Other: Blood samples for pharmacokinetics exploration
- Other: Imagery
- Other: Quality of life scale
- Other: Detection of adverse events
- Genetic: Saliva samples
- Genetic: Blood sample
- Other: Biological statement
- Other: Clinical examination
Primary outcomes (2)
- measure
- Evaluation of clinically significant side effect occurence with plasma balance mean concentration in ibrutinib
- timeFrame
- 1 months after treatment initiation
- description
- Plasma balance mean will be calculated with 6 blood samples collected at regular intervals during the visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Evidence of Chronic Lymphocytic Leukaemia (CLL), or Follicular Lymphoma (FL) or Mantle cell lymphoma (MCL) and a first prescription of idelalisib or ibrutinib * Patients must give written informed consent * Patients with Health Insurance System Exclusion Criteria: * Patient who several blood tests can't be performed (poor venous access) * Patients under legal guardian * Pregnant or breastfeeding women
References
Publications (2)
- DERIVEDCadot S, Audebert C, Dion C, Ken S, Dupre L, Largeaud L, Laurent C, Ysebaert L, Crauste F, Quillet-Mary A. New pharmacodynamic parameters linked with ibrutinib responses in chronic lymphocytic leukemia: Prospective study in real-world patients and mathematical modeling. PLoS Med. 2024 Jul 22;21(7):e1004430. doi: 10.1371/journal.pmed.1004430. eCollection 2024 Jul. PMID 39037964
- DERIVEDGallais F, Ysebaert L, Despas F, De Barros S, Dupre L, Quillet-Mary A, Protin C, Thomas F, Oberic L, Allal B, Chatelut E, White-Koning M. Population Pharmacokinetics of Ibrutinib and Its Dihydrodiol Metabolite in Patients with Lymphoid Malignancies. Clin Pharmacokinet. 2020 Sep;59(9):1171-1183. doi: 10.1007/s40262-020-00884-0. PMID 32328976