Chronic lymphocytic leukemia Mantle cell lymphoma Hodgkin-Lymphoma Renal cell carcinoma Squamous cell carcinoma of the head and neck area Malignant melanoma
Conditions
Interventions
Group 1: Baseline examination (detailed medical history and survey of previous illnesses, questionnaire on sporting activity).
Determination of vital signs, a 12-lead ECG, an LCEKG if necessary, and a
ECG is used to determine PR interval.
A history of comedication of possible interactions via CYP3A4 is also obtained.
In patients prior to initiation of therapy with a checkpoint inhibitor, the foll
Sponsors
Universitätsklinikum KölnKlinik III für Innere Medizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients prior to initiation of a therapy with a checkpoint inhibitor for the treatment of a malignant disease • Patients prior to initiation of a therapy or under therapy with a BTK inhibitor for the treatment of a malignant disease • Patients prior to initiation of a therapy with the combination of BRAF and MEK inhibitors for the treatment of a malignant disease • Age> 18 years • Educational ability: The patient must be able to understand and to sign the declaration of consent. He must be sufficiently proficient in the German language.
Exclusion criteria
Exclusion criteria: • Lack of consent • Pregnant or breastfeeding women • Patient depending on or in relation to the sponsor or PI • Life expectancy <12 months due to illness • Patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For patients under / after therapy with BTKI: • Occurrence and quantification of the following cardiac arrhythmias in the ECG / Long-term ECG: Atrial fibrillation, atrial flutter, atrial tachycardia, ventricular tachycardia • Occurrence of left ventricular dysfunction (ejection fraction, diastolic dysfunction, global longitudinal strain) in echocardiography • Arterial hypertension (defined as newly emerged hypertension or deterioration of pre-existing hypertension by 10mmHg in two independent measurements) For patients under / after therapy with a checkpoint inhibitor: • Occurrence of (peri-) myocarditis diagnosed according to current guidelines of the European Cardiology Society • Occurrence of relevant troponin dynamics • Occurrence of cardiac arrhythmias (AV blockages, atrial fibrillation / flutter, ventricular tachycardia) in the 12-lead ECG • Occurrence of left ventricular dysfunction (ejection fraction, diastolic dysfunction, global longitudinal strain) in echocardiography For patients under / after therapy combination with BRAF / MEK inhibitors: • Occurrence of left ventricular dysfunction (ejection fraction, diastolic dysfunction, global longitudinal strain) in echocardiography • Arterial hypertension (defined as newly occurring hypertension or deterioration of pre-existing hypertension by 10mmHg in two independent measurements) | — |
Secondary
| Measure | Time frame |
|---|---|
| For patients under / after therapy with BTKI: • Occurrence of relevant troponin dynamics • Occurrence of relevant changes in the complete blood count • Occurrence of relevant changes in the NT-pro BNP For patients under / after therapy with a checkpoint inhibitor: • Occurrence of relevant changes in the complete blood count | — |
Countries
Germany
Contacts
Public ContactFlorian Simon
Universitätsklinikum KölnKlinik I für Innere Medizin
Outcome results
None listed