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| Name | Class |
|---|---|
| University Hospital, Marseille | OTHER |
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
| European Georges Pompidou Hospital | OTHER |
| Hôpital Necker-Enfants Malades |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hematologic malignancy patients requiring a treatment by Bruton's tyrosine kinase inhibitor | Other | Consecutive adult patients with a definite diagnosis of hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) during at least 12 months will be included to receive an insertable subcutaneous cardiac monitor (ISCM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) | Device | Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure. | 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days) | |
| The occurrence of bleeding events from inclusion and within 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Alexandre, MD, PhD | Contact | +33 2.31.06.46.71 | alexandre-j@chu-caen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital, Department of Pharmacology | Caen | Normandy | France |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D066126 | Cardiotoxicity |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| OTHER |
| Saint Antoine University Hospital | OTHER |
| Hospices Civils de Lyon | OTHER |
| Centre Hospitalier Universitaire de Saint Etienne | OTHER |
| Biotronik SE & Co. KG | INDUSTRY |
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| 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. | 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days) |
| IRAF management. | 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. | 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. | 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. | 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days) |
| Constitute a plasmatic biobank for futures ancillary studies. | 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. | 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |