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NCT07828535Not yet recruitingPhase 1

Liposomal Mitoxantrone Plus Azacitidine and Venetoclax in Newly Diagnosed Elderly or Unfit AML

A Phase Ib Study of Liposomal Mitoxantrone Combined With Azacitidine and Venetoclax in Newly Diagnosed Elderly or Unfit Patients With Acute Myeloid Leukemia

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

This prospective, open-label, multicenter phase Ib trial will evaluate the safety, tolerability, and RP2D of the VAM regimen (liposomal mitoxantrone + azacitidine \[AZA\] + venetoclax \[VEN\]) in elderly or unfit patients with newly diagnosed AML. A standard 3+3 dose escalation will enroll 12-30 patients, testing liposomal mitoxantrone at 8, 12, 16, and 20 mg/m². VEN duration (9 vs. 14 days) will be determined at the 8 mg/m² dose level, after which only liposomal mitoxantrone will be escalated while AZA and VEN will remain fixed. Induction therapy will consist of up to two 28-day cycles. Responders achieving CR/CRi/MLFS will be eligible for up to 4 consolidation cycles (total ≤6 cycles), after which they will proceed to maintenance with either AZA+VEN or observation.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
15 Sept 2026
Start date
Oct 2026
Primary completion date
Dec 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT07828535

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 30
  • From Oct 2026 to the primary completion date, Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Subjects who meet any of the following criteria will not be eligible for enrollment in this study:
    • Acute promyelocytic leukemia (APL)..
    • Active central nervous system (CNS) leukemia.
    • Prior targeted therapy or chemotherapy for AML, excluding hydroxyurea.
    • Uncontrolled active infection.
    • Uncontrolled cardiovascular disease: New York Heart Association (NYHA) class III-IV heart failure, myocardial infarction or unstable angina within 6 months before enrollment, or uncontrolled hypertension.
    • Left ventricular ejection fraction (LVEF) \< 40%.
    • Concurrent active malignancy, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer.
    • Known hypersensitivity to the study drugs or their excipients.
    • Pregnant or breastfeeding women.
    • Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation.

Who the study is looking for

  • Subjects eligible for enrollment in this study must meet all of the following criteria:
    • Diagnosis of acute myeloid leukemia (AML) according to the WHO 2022 or ICC criteria, excluding acute promyelocytic leukemia (APL).
    • No prior therapy for AML, except hydroxyurea for the management of hyperleukocytosis.
    • Meeting at least one of the following criteria:
    • Age ≥ 75 years;
    • Age 18-74 years with at least one of the following conditions precluding suitability for intensive chemotherapy:
    • ECOG performance status 2-3; ii. Cardiac dysfunction with left ventricular ejection fraction (LVEF) ≤ 50%; iii. Pulmonary dysfunction with diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; iv. Creatinine clearance 30-45 mL/min; v. Other major organ dysfunction or comorbidities that, in the investigator's judgment, render the patient unsuitable for intensive chemotherapy.
    • ECOG performance status 0-3.
    • Life expectancy ≥ 3 months.
    • Patients of childbearing potential agree to use effective contraception during the treatment period and for at least 6 months after the last dose of study treatment.
    • Voluntary written informed consent provided.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.