Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib
NCT ID: NCT02824159
Last Updated: 2020-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
121 participants
OBSERVATIONAL
2016-04-30
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pharmacokinetic properties of these two drugs highlight an interindividual pharmacokinetic considerable variability. The aim of this clinical research study is to determine the association between clinically significant side effects occurrence during the first year of treatment (serious adverse reaction and/or grade CTCAE ≥ 3 and/or leading a dosage concession) and plasma mean concentration of the steady state of ibrutinib or idelalisib performed at 1 month.
To determine plasma mean concentration of the steady state of ibrutinib or idelalisib, blood tests will be performed every scheduled monitoring at visit 1 month during a pharmacokinetic exploration and during scheduled medical consultation (2, 3, 6 and 12 months) and every unscheduled visit in case of side effect occurrence.
Every scheduled monitoring visit, blood tests will be performed to determine plasma concentration in drug. Complementary blood or salivary samples will be collected before the treatment, 24 months later and in case of relapse to determine genetic characteristics. In parallel, a logbook will be completed by the patient to collect side effects. Finally, an oncology certified nurse call patients every 2 weeks. In case of side effect occurrence a visit will be organized in the next 3 days and a blood test will be performed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patient with haematologic malignancies
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
Blood samples for pharmacokinetics exploration
6 blood sample at regular intervals
Imagery
Efficacity will be assessed with 3 sessions of resonance magnetic imaging or positron emission tomography scan
Quality of life scale
Quality of life will be evaluated with questionaries 5 times during the study
Detection of adverse events
The detection will be assessed using the AMA (assistance des malades ambulatoires) system
Saliva samples
Saliva samples will be collected to explore genetic characteristics of germinal DNA (genes involved in drug pharmacokinetic)
Blood sample
A unique blood sample will be performed in order to determine characteristics of tumoral DNA (resistance to treatment mutation)
Biological statement
The following parameters will be assessed :
* Complete blood count
* Hemoglobin
* Hepatic enzymes
* Creatinine clearance
* Lactate dehydrogenase rate
* Total bilirubin rate
* Cluster of differentiation 4 T lymphocytes rate
* Total gamma-globulins rate
Clinical examination
The clinical examination are composed by :
* Weigh, Height and body mass index measurement
* Clinical state of patient during examination
* Stage of the disease (OMS grade, binet classification, Ahn Arbor classification)
* Presence of B symptomatology
* Prognostic factors (Genetic, Mantle Cell Lymphoma International Prognostic Index, Follicular Lymphoma International Prognostic Index, presence of lymph nodes, other target organs ...)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood samples for pharmacokinetics exploration
6 blood sample at regular intervals
Imagery
Efficacity will be assessed with 3 sessions of resonance magnetic imaging or positron emission tomography scan
Quality of life scale
Quality of life will be evaluated with questionaries 5 times during the study
Detection of adverse events
The detection will be assessed using the AMA (assistance des malades ambulatoires) system
Saliva samples
Saliva samples will be collected to explore genetic characteristics of germinal DNA (genes involved in drug pharmacokinetic)
Blood sample
A unique blood sample will be performed in order to determine characteristics of tumoral DNA (resistance to treatment mutation)
Biological statement
The following parameters will be assessed :
* Complete blood count
* Hemoglobin
* Hepatic enzymes
* Creatinine clearance
* Lactate dehydrogenase rate
* Total bilirubin rate
* Cluster of differentiation 4 T lymphocytes rate
* Total gamma-globulins rate
Clinical examination
The clinical examination are composed by :
* Weigh, Height and body mass index measurement
* Clinical state of patient during examination
* Stage of the disease (OMS grade, binet classification, Ahn Arbor classification)
* Presence of B symptomatology
* Prognostic factors (Genetic, Mantle Cell Lymphoma International Prognostic Index, Follicular Lymphoma International Prognostic Index, presence of lymph nodes, other target organs ...)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must give written informed consent
* Patients with Health Insurance System
Exclusion Criteria
* Patients under legal guardian
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Toulouse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Loïc Ysebaert, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer University Institute of Toulouse Oncopole
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer University Institute of Toulouse Oncopole
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cadot 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.
Gallais 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-005572-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15 7754 07
Identifier Type: -
Identifier Source: org_study_id