This is a multicenter, open-label, phase II study to evaluate the cardiac safety of Mitoxantrone Hydrochloride Liposome in patients with advanced malignant tumor who has received at least first-line treatment.
This is a multicenter, open-label, phase II study to evaluate the cardiac safety of Mitoxantrone Hydrochloride Liposome in patients with advanced malignant tumor who has received at least first-line treatment. About 120 patients will be recruited in this study. Patients with solid tumors will receive Mitoxantrone Hydrochloride Liposome 20 mg/m\^2 by an intravenous infusion (IV) every 3 weeks (q3w, 1 cycle). Patients with lymphoma will receive Mitoxantrone Hydrochloride Liposome 20 mg/m\^2 by an intravenous infusion (IV) every 4 weeks (q4w, 1 cycle). All the patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator's or patient's decision.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV), 20 mg/m\^2. Solid tumors: every 3 weeks (q3w, 1 cycle), Lymphoma: every 4 weeks (q4w, 1 cycle).
the first affiliated hospital of Dalian medical university
Dalian, Liaoning, China
Cardiac adverse event
Time frame: up to approximately 5 years.
Overall response rate (ORR)
Time frame: up to approximately 3 years
Progression-free survival (PFS)
Time frame: up to approximately 3 years.
Overall survival (OS)
Time frame: up to approximately 5 years
Incidence of treatment emergent adverse event (TEAE)
Time frame: up to approximately 3 years.
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