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Single-arm, prospective, multi-center clinical study of mitoanthraquinone hydrochloride liposomes combined with azacytidine and venetoclax regimen for the treatment of primary acute myeloid leukemia

Single-arm, prospective, multi-center clinical study of mitoanthraquinone hydrochloride liposomes combined with azacytidine and venetoclax regimen for the treatment of primary acute myeloid leukemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093555
Enrollment
Unknown
Registered
2024-12-06
Start date
2024-10-17
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

Test group:Mitoanthraquinone hydrochloride liposomes combined with azacytidine and Venecla regimen

Sponsors

Tangdu Hospital, Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients are fully aware of this study and voluntarily participate and sign an informed consent form. 2.Age >=18 years old. 3.The initial treatment of acute myeloid leukemia (non-APL) diagnosed by clinical diagnosis. 4.Normal heart function Y heart ejection fraction >=50%. 5.Liver and kidney function: Alanine aminotransferase (ALT) and aspartic acid aminotransferase (AST) <=2.5 times the upper limit of normal value (ULN) (<=5 times the upper limit of normal value for patients with liver infiltration), total bilirubin <=1.5 times the upper limit of normal value, serum creatinine <=1.5 times the upper limit of normal value. 6.Eastern Oncology Collaborative Group (ECOG) Physical fitness Score: 0-2 points.

Exclusion criteria

Exclusion criteria: 1.Those who have suffered from other malignant tumors in the past or are in need of treatment at the same time. 2.Uncontrollable systemic diseases: such as uncontrollable high blood pressure due to active infections in the progressive stage. 3.Suffering from leukemia of the central nervous system. 4.There is a known history of immediate or delayed hypersensitivity to similar drugs and excipients of the studied drugs. 5.Patients who refused to take effective contraceptive measures during the study of pregnant and lactating women. 6.Accompanied by a history of severe nervous or mental illness. 7.There are other serious diseases such as severe myocardial infarction or unstable angina pectoris and severe arrhythmia. 8.Cerebrovascular events: including transient cerebral ischemia, etc. 9.Subjects who are known to be infected with human immunodeficiency virus, hepatitis B, hepatitis C active infection, carriers of inactive hepatitis, or subjects with low titers of viral hepatitis virus after treatment with non-banned antiviral drugs will not be excluded. 10.Subjects who received strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment. 11.Patients who cannot take oral drugs or have malabsorbent syndrome. 12.The researchers judged that there were patients who were not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Compound remission rate after treatment;

Secondary

MeasureTime frame
Micro-residual disease to negative rate;1-year event-free survival rate;1-year overall survival rate;Hematological and non-hematological toxicity;

Countries

China

Contacts

Public ContactWeiwei Qin

Tangdu Hospital, Fourth Military Medical University

vivianq1126@126.com+86 181 8265 7655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026