New treatment for elderly patients with acute myeloid leukemia

A Prospective, Single-arm, Multi-center, Phase 2 Clinical Study of Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

This study is testing a new combination treatment for older patients who have just been diagnosed with acute myeloid leukemia to see if it helps them live longer without their cancer getting worse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 60 Years to 70 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06621199 on ClinicalTrials.gov

What this trial studies

This phase 2 trial evaluates the safety and efficacy of a combination treatment using mitoxantrone hydrochloride liposome, cytarabine, and venetoclax in elderly patients newly diagnosed with acute myeloid leukemia (AML). The study aims to include 42 patients, accounting for potential dropouts, and focuses on achieving a 2-year event-free survival as the primary endpoint. The treatment regimen consists of two cycles of the combination therapy, followed by consolidation and maintenance therapy based on individual risk stratification. Patients will be monitored throughout the treatment and follow-up periods.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 60-70 years with newly diagnosed primary AML who meet specific health criteria.

Not a fit: Patients with acute promyelocytic leukemia or secondary AML from previous treatments will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for elderly patients with newly diagnosed AML.

How similar studies have performed: While this approach is innovative, similar studies have shown promising results with combination therapies in AML treatment.

Eligibility criteria

Inclusion Criteria:

1. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
2. Aged 60-70 years (including boundary values 60 and 70);
3. Newly diagnosed primary AML according to the WHO 2022 classification.
4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
5. Life expectancy ≥ 3 months.
6. ALT/AST≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.

Exclusion Criteria:

1. Subjects meet any of the following conditions:

   1. Acute promyelocytic leukemia;
   2. Secondary AML caused by chemotherapy and/or radiotherapy to treat solid tumor or antecedent hematological disorders such as MDS, MPN, MDS/MPN;
   3. AML following blast transformation of prior chronic myeloid leukemia;
   4. Central nervous system (CNS) leukemia;
2. Subjects with malignant tumors (excluding cured skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past 5 years) within the past 5 years.
3. Subjects who have received anthracycline pretreatment or other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments);
4. Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
5. Subjects who are unable to take oral medications or have malabsorption syndrome;
6. Cardiac function and disease conform to one of the following conditions:

   1. Long QTc syndrome or QTc interval \>480 ms;
   2. Complete left bundle branch block, degree II or III atrioventricular block;
   3. Severe, uncontrolled arrhythmia requiring medical treatment;
   4. New York Heart Association(NYHA) classification ≥ grade II;
   5. Cardiac ejection fraction (EF) was less than 50%;
   6. A history of myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiogram evidence of acute ischemic or active conduction abnormalities within 6 months prior to enrollment;
7. Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
8. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
9. HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; HCV Ab positive, with HCV-RNA≥1x10\^3 copies/mL;
10. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
11. With a history of severe neurological or psychiatric illness.
12. Not suitable for this study as decided by the investigator.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jie Jin, M.D.

Conditions Acute Myeloid Leukemia