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

Last updated: March 12, 2024
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

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

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

Mitoxantrone hydrochloride liposome injection24mg/m2

Clinical Study ID

NCT05941585
HE071-032
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 90
Treatment Group(s): 10
Primary Treatment: Cytarabine(standard-dose:d1-d7100mg/m2/day)
Phase:
Study Start date:
August 08, 2023
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020
    China

    Active - Recruiting

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