MedTrace Logo

Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib

NCT02824159 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2020-12-28

No results posted yet for this study

Summary

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

Interventions

OTHER

Blood samples for pharmacokinetics exploration

6 blood sample at regular intervals

OTHER

Imagery

Efficacity will be assessed with 3 sessions of resonance magnetic imaging or positron emission tomography scan

OTHER

Quality of life scale

Quality of life will be evaluated with questionaries 5 times during the study

OTHER

Detection of adverse events

The detection will be assessed using the AMA (assistance des malades ambulatoires) system

GENETIC

Saliva samples

Saliva samples will be collected to explore genetic characteristics of germinal DNA (genes involved in drug pharmacokinetic)

GENETIC

Blood sample

A unique blood sample will be performed in order to determine characteristics of tumoral DNA (resistance to treatment mutation)

OTHER

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

OTHER

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 ...)

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Loïc Ysebaert, MD · Cancer University Institute of Toulouse Oncopole

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02824159 on ClinicalTrials.gov