IDARUBICIN HYDROCHLORIDE for Cancer (patients receiving anthracycline-based chemotherapy)

Inclusion criteria

• {"criterion_text":"- Female and male persons > 18 years of age"}
• {"criterion_text":"- Patients to be treated with at least 4 cycles of anthracycline-based antineoplastic therapy"}
• {"criterion_text":"- Written informed consent form"}

Exclusion criteria

• {"criterion_text":"- Lack of capacity to consent"}
• {"criterion_text":"- Patients who have already received anthracycline therapy"}
• {"criterion_text":"- Persons who have received therapy with the following myocardial-toxic drugs within the last 6 months prior to study inclusion - High-dose cyclophosphamide (>1000mg/m2, >10mg/kg) - HER2 inhibitors - VEGF inhibitors - BCR-ABL inhibitors - BRAF inhibitors - MEK inhibitors - Immune checkpoint inhibitors (CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors)"}
• {"criterion_text":"- Therapy with fewer than 4 planned cycles of antracycline-containing therapy (e.g. induction therapy for AML)"}
• {"criterion_text":"- Therapies in which antracyclines are not applied in every cycle"}
• {"criterion_text":"- Planned invasive cardiac procedure during the study period"}
• {"criterion_text":"- Known cardiac involvement of an existing disease, e.g. amyloidosis"}
• {"criterion_text":"- Treatment with liposomal forms of therapy, such as liposomal daunorubicin/cytarabine (CPX-351) or liposomal doxorubicin"}
• {"criterion_text":"- Radiotherapy with a thoracic radiation field that was performed prior to the planned anthracycline-containing therapy (radiotherapy for non-thoracic lesions prior to study inclusion is not considered an exclusion criterion)"}
• {"criterion_text":"- Simultaneous participation in another clinical trial or previous participation in another clinical trial in the last 3 months prior to study inclusion"}
• {"criterion_text":"- Kidney damage with a GFR <30 ml/min/1.73 m²"}
• {"criterion_text":"- Patients in the perioperative phase of a liver transplantion"}
• {"criterion_text":"- Metal implants, e.g. cardiac pacemakers, which are a contraindication for an MRI examination"}
• {"criterion_text":"- Vulnerable population (persons who are unable to protect and represent their own interests with regard to illness, disability, mental illness, intellectual development, cognitive impairment and prisoners) are not included in this study"}
• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- Known hypersensitivity to contrast agents containing gadolinium"}
• {"criterion_text":"- Patient information not possible (e.g. language barrier)"}

Primary endpoints

• {"endpoint_text":"- Changes in the T2-weighted relaxation time in myocardial mapping","definition_or_measurement_approach":"T2-weighted relaxation time measured by cardiac magnetic resonance imaging (CMR) myocardial mapping"}

Secondary endpoints

• {"endpoint_text":"- Further abnormal CMR findings (morphology, function, perfusion, LGE and residual parametric mapping (T1-weighted relaxation time, extracellular volume)) during and after completion of anthracycline-based chemotherapy, analyzed by two different investigators","definition_or_measurement_approach":"Abnormal findings on CMR including morphology, function, perfusion, late gadolinium enhancement (LGE) and parametric mapping (T1, extracellular volume); assessed during and after therapy and analyzed by two investigators"}
• {"endpoint_text":"- Troponin T and NT-proBNP before, during and after completion of anthracycline-based chemotherapy in correlation with CMR results","definition_or_measurement_approach":"Serial blood measurements of Troponin T and NT-proBNP at specified timepoints before, during and after chemotherapy correlated with CMR findings"}
• {"endpoint_text":"- Echocardiographically determined Global Longitudinal Strain before, during and after completion of anthracycline-based chemotherapy in correlation to CMR results","definition_or_measurement_approach":"Echocardiographic assessment of Global Longitudinal Strain at defined timepoints correlated with CMR"}
• {"endpoint_text":"- Validation and/or identification of new biomarkers (e.g. genetic markers) using the biomaterials","definition_or_measurement_approach":"Biomarker discovery/validation using collected biomaterials (e.g. genetic marker analysis) per protocol laboratory analyses"}

Germany

Earliest CTIS Part Ii Submission Date

30-07-2025

Latest Decision Or Authorization Date

08-08-2025

Processing Time Days

9

Number Of Sites

1

Number Of Participants

93

Primary sponsor

Full Name

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany