Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib

CompletedOBSERVATIONAL
Enrollment

121

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

November 30, 2020

Study Completion Date

December 31, 2020

Conditions
Hematological Malignancies
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 ...)"

Trial Locations (1)

31059

Cancer University Institute of Toulouse Oncopole, Toulouse

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER

NCT02824159 - Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib | Biotech Hunter | Biotech Hunter