The goal of this clinical trial is to screen all types of electrocardiographic changes and rhythm disorders in adult patients with a hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) using an insertable subcutaneous cardiac monitor (ISCM) and occurring from inclusion and within 12 months. This study consists of the implantation of an ISCM at inclusion and before BTK inhibitor initiation. Then patients will have medical visits every 3 months (+/- 7 days) during 12 months and a continuous cardiac telemonitoring using the ISCM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment.
Caen University Hospital, Department of Pharmacology
Caen, Normandy, France
Occurrence of any electrocardiographic changes and/or rhythm disorders from first BTK inhibitors prescription to 12 months of follow-up, symptomatic or not, detected on 12-lead ECG and/or on ISCM.
Electrocardiographic changes and/or rhythm disorders are defined by the European Society of Cardiology guidelines.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
The occurrence of bleeding events from inclusion and within 12 months.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Correlation between IRAF and multiple demographic, clinical, cardiac imaging (morphological data) and serum cardiac biomarkers.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
IRAF management.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Progression-free survival of patients treated by BTK inhibitors according to the presence of IRAF.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Correlation between QT/QTc measurements performed by ISCM (BIOMONITOR IIIm®, Biotronik®) and a QT expert on 12-leads ECG.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Daily body temperature monitoring with the ISCM (BIOMONITOR IIIm®, Biotronik®) temperature sensor and will be compared with conventional body temperature measurements performed during follow-up visits.
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Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Constitute a plasmatic biobank for futures ancillary studies.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
The need for ISCM (BIOMONITOR IIIm®, Biotronik®) remove within the 12-months follow-up.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)