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 range
18 Years – 75 Years
Sex
ALL
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.）；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)；
. Serum biomarkers：
. 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.