The purpose of this study is to determine the safety, efficacy and pharmacokinetics of mitoxantrone hydrochloride liposome injection combined with chemotherapy in previously untreated de novo acute myeloid leukemia.
This is a prospective, multi-center, randomized, open-label, three-arm clinical study to explore the efficacy among three chemotherapy regimens combined with mitoxantrone hydrochloride liposome in previously untreated de novo acute myeloid leukemia. Patients will be randomized to different treatment group and be given different induction therapy in the first cycle. If patients do not achieve Morphologic Leukemia-free State (MLFS) after the first induction cycle, they will receive the second induction therapy with mitoxantrone hydrochloride liposome, cytarabine and venetoclax. Mitoxantrone hydrochloride liposome will be given on day 1 at the dose of 24 mg/m2 or 30 mg/m2 and be combined with cytarabine, venetoclax or homoharringtonine. A maximum of 2 cycles of induction therapy are planned.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (30mg/m2)
Homoharringtonine intravenous infusion on D1-D7,2mg/m2/day in a 4-week treatment cycle.
Venetoclax d4-d12 (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)in a 4-week treatment cycle.
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Incidence of treatment-emergent adverse events (TEAEs)
The frequency and severity of adverse events during treatment, abnormalities in vital signs, physical examinations, laboratory tests, etc
Time frame: Up to approximately one month
Complete remission rate(CR)
Proportion of patients with complete remission
Time frame: Up to approximately nine weeks
Complete remission or complete remission with partial hematologic recovery (CR/CRh)
Proportion of patients with complete remission or complete remission with partial hematologic recovery.
Time frame: Up to approximately nine weeks
Composite remission rate (CRc)
Proportion of subjects with complete remission (CR) or complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (Cri).
Time frame: Up to approximately nine weeks
Minimal Residual Disease (MRD)-negative composite remission rates
Among those who have achieved composite remission, proportion of patients who is MRD-negative.
Time frame: Up to approximately nine weeks
Event-free survival (EFS)
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
Time frame: Up to approximately 3 years.
Relapse-free Survival (RFS)
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cytarabine intravenous infusion on d1-d7 ,100mg/m2/day
d1-d4100mg/m2/day, d5-d7 1g/m2
Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (24mg/m2)
Time frame: Up to approximately 3 years.
Overall survival (OS)
It is defined as the time from the start of randomization to the death from any cause.
Time frame: Up to approximately 3 years.
Blood concentrations of total and free mitoxantrone.
Blood was taken to measure the required concentration at different time points
Time frame: 30 minutes before administration and 5min, 6, 24, 72, 144, 288, 432, 648 hours after administration of Mitoxantrone hydrochloride liposome on day 1