New treatment for elderly patients with acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Jie Jin, M.D.
• Email: jiej0503@163.com
• Phone: +86 571-87236896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.