Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia

NCT05941585 | Completed

• 1 other identifier: IIT2023004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

  Up to approximately one month

Secondary Outcomes (8)

• Complete remission rate（CR）

  Up to approximately nine weeks

• Complete remission or complete remission with partial hematologic recovery (CR/CRh)

  Up to approximately nine weeks

• Composite remission rate (CRc)

  Up to approximately nine weeks

• Minimal Residual Disease (MRD)-negative composite remission rates

  Up to approximately nine weeks

• Event-free survival (EFS)

  Up to approximately 3 years.

Study Arms (3)

mitoxantrone hydrochloride liposome injection combined with of cytarabine

EXPERIMENTAL

Patients will receive mitoxantrone hydrochloride liposome injection combined with standard-dose of cytarabine.

Drug: Mitoxantrone hydrochloride liposome injection30mg/m2; Drug: Cytarabine(standard-dose:d1-d7100mg/m2/day)

mitoxantrone hydrochloride liposome with cytarabine and homoharringtonine

EXPERIMENTAL

Patients will receive mitoxantrone hydrochloride liposome injection combined with intermediate-dose of cytarabine and homoharringtonine.

Drug: HomoharringtonineD1-D7(2mg/m2/day); Drug: Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2); Drug: Mitoxantrone hydrochloride liposome injection24mg/m2

mitoxantrone hydrochloride liposome injection combined with cytarabine and venetoclax

EXPERIMENTAL

Patients will receive mitoxantrone hydrochloride liposome injection with cytarabine and venetoclax.

Drug: Mitoxantrone hydrochloride liposome injection30mg/m2; Drug: Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day); Drug: Cytarabine(standard-dose:d1-d7100mg/m2/day)

Interventions

Mitoxantrone hydrochloride liposome injection30mg/m2 DRUG

Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (30mg/m2)

mitoxantrone hydrochloride liposome injection combined with cytarabine and venetoclax; mitoxantrone hydrochloride liposome injection combined with of cytarabine

HomoharringtonineD1-D7(2mg/m2/day) DRUG

Homoharringtonine intravenous infusion on D1-D7,2mg/m2/day in a 4-week treatment cycle.

mitoxantrone hydrochloride liposome with cytarabine and homoharringtonine

Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day) DRUG

Venetoclax d4-d12 (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)in a 4-week treatment cycle.

mitoxantrone hydrochloride liposome injection combined with cytarabine and venetoclax

Cytarabine(standard-dose:d1-d7100mg/m2/day) DRUG

Cytarabine intravenous infusion on d1-d7 ,100mg/m2/day

mitoxantrone hydrochloride liposome injection combined with cytarabine and venetoclax; mitoxantrone hydrochloride liposome injection combined with of cytarabine

Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2) DRUG

d1-d4100mg/m2/day, d5-d7 1g/m2

mitoxantrone hydrochloride liposome with cytarabine and homoharringtonine

Mitoxantrone hydrochloride liposome injection24mg/m2 DRUG

Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (24mg/m2)

mitoxantrone hydrochloride liposome with cytarabine and homoharringtonine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the study and voluntarily sign informed consent.
• Age: 18\~65 (including 18) years old, gender unlimited.
• Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
• Eastern Cooperative Oncology Group (ECOG) physical state score: 0-1.
• Fit for intensive chemotherapy.
• The function of main organs should meet the following standards before treatment:
• Kidney: Serum creatinine ≤ 1.5 × Upper limit of normal range (ULN) Liver: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3× ULN
• Patients should agree to use contraception (such as intrauterine device \[IUD\], contraceptive pill or condom) during the study period and within 6 months after the end of the study; Female patients must have a negative serum pregnancy test within 7 days before enrollment.

You may not qualify if:

• Any of the following cases:(1) diagnosed as acute promyelocytic leukemia (APL);(2) chronic myelogenous leukemia in blast crisis;(3) AML with central nervous system leukemia.
• AML arising from prior cytotoxic chemotherapy or radiotherapy for other tumours.
• Patient has been previously diagnosed with another malignancy in last 5 years (except for cured basal cell carcinoma of skin or cervical carcinoma in situ).
• Has been previously treated with doxorubicin or other anthracyclines and drugs for AML.
• Allergic history of mitoxantrone hydrochloride injection or any other drugs used in this study.
• Those on systemic anti-infective therapy with poorly controlled infection (signs of infection progression within 1 week prior to the first dose, or as determined by the investigator).
• Patient who is suffering from severe hemorrhagic diseases, such as haemophilia A, haemophilia B, von Willebrand disease and any other spontaneous bleeding require medical treatment.
• The estimated survival time is less than 3 months.
• Any of the following conditions occurs in cardiac function:(1) Long QTc syndrome or QTc interval \> 480 ms;(2) Complete left bundle branch block or severe atrioventricular block disease (without a pacemaker);(3) Serious and uncontrolled arrhythmias and unstable angina pectoris requiring drug treatment;(4) History of chronic congestive heart failure, New York Heart Association (NYHA)≥grade 3;(5) The cardiac ejection fraction is less than 50% in Echocardiography;(6)Uncontrollable hypertension (defined as multiple measurements of systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg under drug control);(7) History of myocardial infarction, unstable angina pectoris, viral myocarditis or severe pericardial disease, ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before first dose.
• Patients have thromboembolic events within 6 months prior to first dose, such as cerebrovascular accidents (including transient ischemic attack) and pulmonary embolism.
• HBsAg/HBcAb positive with HBV-DNA higher than the lower limit of the detection value of the research center , hepatitis C antibody-positive with HCV-RNA higher than the lower limit of the detection value of the research center, or HIV antibody positive in the preliminary screening.
• Patients who have been treated with strong/moderate CYP3A inducers/inhibitors or P-gp inhibitors within 7 days prior to first dose (for treatment group 3 only).
• Patients who cannot take oral medications or have absorption disorder (for treatment group 3 only).
• Patient is suffering from any serious and /or non-controllable disease, or the investigator determines that the disease might affect the participation of patients in the study, including (but not limited to, uncontrolled diabetes, dialysis related kidney diseases, severe liver diseases, life-threatening autoimmune diseases and hemorrhagic diseases, drug abuse, neurological diseases, etc.).
• Pregnant or lactating female.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• wang jianxiang, MD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 12, 2023
• Study Start: August 8, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-02

Locations

CN (1)