Combining Mitoxantrone with Chemotherapy for Acute Myeloid Leukemia

A Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection Combined With Chemotherapy in Previously Untreated de Novo Acute Myeloid Leukemia

This study is testing if combining a new drug called mitoxantrone with standard chemotherapy can help people with newly diagnosed acute myeloid leukemia respond better to treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 1 site (Tianjin)
• Trial ID: NCT05941585 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of mitoxantrone hydrochloride liposome in combination with various chemotherapy regimens for patients with untreated de novo acute myeloid leukemia. It is a multi-center, randomized, open-label study where participants will be assigned to different treatment groups to receive induction therapy. If patients do not achieve a Morphologic Leukemia-free State after the first cycle, they will receive a second induction therapy. The study will assess the pharmacokinetics and overall response to the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with untreated acute myeloid leukemia and are fit for intensive chemotherapy.

Not a fit: Patients who have previously received treatment for acute myeloid leukemia or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve outcomes for patients with acute myeloid leukemia by enhancing the efficacy of chemotherapy.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in combining targeted therapies with traditional chemotherapy in hematological malignancies.

Eligibility criteria

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 the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven'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: Total bilirubin ≤ 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 the end of the study; Female patients must have a negative serum pregnancy test within 7 days before enrollment.

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 system leukemia.
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 (except for cured basal cell carcinoma of skin or cervical carcinoma in situ).
4. Has been previously treated with doxorubicin or other anthracyclines and drugs for AML.
5. Allergic history of mitoxantrone hydrochloride injection or any other drugs used in this study.
6. 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).
7. 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.
8. The estimated survival time is less than 3 months.
9. 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.
10. Patients have thromboembolic events within 6 months prior to first dose, such as cerebrovascular accidents (including transient ischemic attack) and pulmonary embolism.
11. 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.
12. 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).
13. Patients who cannot take oral medications or have absorption disorder (for treatment group 3 only).
14. 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.).
15. Pregnant or lactating female.
16. Patients who are not suitable for this study as decided by the investigator due to other reasons.

Where this trial is running

Tianjin

• Institute of Hematology & Blood Diseases Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: wang jianxiang, MD — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Jianxiang Wang, MD

Conditions Acute Myeloid Leukemia