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RecruitingPhase 2NCT06621199

Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

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

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

42 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).

Eligibility

Min Age: 60 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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.
  • Aged 60-70 years (including boundary values 60 and 70);
  • Newly diagnosed primary AML according to the WHO 2022 classification.
  • Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
  • Life expectancy ≥ 3 months.
  • 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 Criteria22

  • Subjects meet any of the following conditions:
  • Acute promyelocytic leukemia;
  • Secondary AML caused by chemotherapy and/or radiotherapy to treat solid tumor or antecedent hematological disorders such as MDS, MPN, MDS/MPN;
  • AML following blast transformation of prior chronic myeloid leukemia;
  • Central nervous system (CNS) leukemia;
  • 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.
  • Subjects who have received anthracycline pretreatment or other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments);
  • Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
  • Subjects who are unable to take oral medications or have malabsorption syndrome;
  • Cardiac function and disease conform to one of the following conditions:
  • Long QTc syndrome or QTc interval \>480 ms;
  • Complete left bundle branch block, degree II or III atrioventricular block;
  • Severe, uncontrolled arrhythmia requiring medical treatment;
  • New York Heart Association(NYHA) classification ≥ grade II;
  • Cardiac ejection fraction (EF) was less than 50%;
  • 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;
  • Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
  • Human immunodeficiency virus (HIV) infection (HIV antibody positive);
  • HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; HCV Ab positive, with HCV-RNA≥1x10\^3 copies/mL;
  • A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
  • With a history of severe neurological or psychiatric illness.
  • Not suitable for this study as decided by the investigator.

Interventions

DRUGMitoxantrone hydrochloride liposome

Mitoxantrone hydrochloride liposome 24 mg/m\^2 on day 1, every 4 weeks

DRUGCytarabine

Cytarabine 100 mg/m\^2 on day 1-5, every 4 weeks

DRUGVenetoclax

Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks

Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06621199

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