A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxi… (NCT06092606) | Clinical Trial Compass
UnknownPhase 2
A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients
China90 participantsStarted 2023-04-04
Plain-language summary
Purpose：1. Preliminary evaluation of the preventive effect of DH001 on doxorubicin-induced cardiotoxicity in cancer patients 2.To explore appropriate dosages to provide basis for dosages in subsequent confirmatory studies 3.To evaluate the effect of DH001 on the efficacy of doxorubicin treatment in cancer patients 4.To evaluate the safety of DH001 in cancer patients treated with doxorubicin
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Lymphoma：
✓. Lymphoma patients confirmed by histopathology；
✓. No previous history of anthracyclines treatment；
✓. Doxorubicin treatment planned for no less than 6 cycles；
✓. Subjects with malignant tumors (breast cancer, soft tissue sarcoma, etc.) confirmed by histopathology and/or cytology；
✓. Subjects planned to be treated with doxorubicin continuously for no less than 4 cycles（The cumulative dose of doxorubicin is no less than 240 mg/m2.）；
✓. Subjects with no history of systemic chemotherapy involving anthracyclines； 2.Age 18-75 years old, male or female； 3.ECOG PS score 0-1； 4.Expected survival ≥24 weeks； 5. Vital organs function well, that is, relevant examination indicators within 14 days before randomization meet the following requirements：
✕. QTc \> 450ms (men); QTc \> 470ms (women) (QTc interval calculated using the Fridericia Formula; if QTc is abnormal, it can be detected three times continuously with an interval of 2 minutes, and the average value is then taken)；
. Cardiac troponin T (cTnT, if applicable): cTnT \> upper limit of normal ；
✕. cardiac troponin I（cTnI）：cTnI\>upper limit of normal；
✕. N-terminal pro-BNP：NT-proBNP≥upper limit of normal；
✕. B-type natriuretic peptide（BNP，if applicable）：BNP≥upper limit of normal； 4）New York Heart Association Classification (NYHA standards) of cardiac function \>Class II； 5） Unstable angina； 6） Heart failure； 7） Moderate valvular heart disease or above; 8） Myocardial infarction within 1 year before enrollment； 9）Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention； 5.Subjects with high blood pressure that is not well controlled using antihypertensive medication (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) (based on the average of BP readings obtained from ≥2 measurements)，the above parameters are allowed to be achieved through the use of antihypertensive therapy；Subjects with a history of hypertensive crisis or hypertensive encephalopathy； 6.Subjects with type 1 diabetes（T1D）; 7.Subjects with a body mass index ≥28 kg/m2； 8.Subjects with a history of previous heart transplant or complex congenital heart disease.
✕.Subjects that have undergone major surgical treatment (except for diagnosis) within 4 weeks before enrollment or are expected to require major surgical treatment during the study period (except for tumor resection surgery)； 10.Subjects with congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation； 11.Subjects with known active infections or active pulmonary tuberculosis infections shall not be included in the study；However, patients infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) whose condition is stable after antiviral treatment can be enrolled.