Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia

Sponsor
Shanghai Jiao Tong University School of Medicine
Study ID
NCT07486726
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Myeloid Leukemia (AML)
  • Refractory Acute Myeloid Leukemia (AML)
  • Relapse Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aclarubicin — DRUG
    Induction (Cycle1) Phase I starting dose 20mg/m\^2 D1-D2 (dose group 1), 20mg/m2 D1-D3 (dose group 2), 20mg/m2 D1-D4 (dose group 3), ivgtt, Qd The Phase II dose was determined based on the Phase I results Consolidation (Cycle 2-6) Phase I starting dose 20mg/m\^2 D1-D2 (dose group 1), 20mg/m2 D1-D3 (dose group 2), 20mg/m2 D1-D4 (dose group 3), ivgtt, Qd The Phase II dose was determined based on the Phase I results
  • Venetoclax — DRUG
    Cycle 1 (Induction) 100mg on day 1, 200mg on day 2, 400mg on days 3-14 Cycles 2-6 (Consolidation) 400 mg orally daily on days 1-7
  • Azacitidine — DRUG
    Cycle 1 (Induction) 75 mg/m\^2 SC on days 1-7 of each cycle Cycles 2-6 (Consolidation) 75 mg/m\^2 SC on days 1-7 of each cycle Cycles 7-18 (Maintenance) 50 mg/m\^2 SC on days 1-5 of each cycle

Study Details

Acute myeloid leukemia Acute myeloid leukemia (AML) is a clonal hematopoietic cancer that disrupts normal hematopoiesis, ultimately leading to bone marrow failure and death. The annual incidence rate of AML is 4.1 per 100000 people in the US and is higher in patients older than 65 years. There has been a steady improvement in survival over the decades, more noticeably so in younger patients and in the last decade. Azacitidine and Venetoclax is now the standard treatment of newly diagnosed AML ineligible for intensive chemotherapy, while still facing the dilemma of relapse and refractory disease. Anthracycline-based chemotherapeutics were wildly used in the treatment of fit AML patients. While the cardiovascular toxicity leading to morbidity and mortality limited the use of daunorubicin/idarubicin in unfit patients. Aclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. CAG regimen, combined with low-dose cytarabine, aclarubicin and G-CSF has been widely used in China and Japan for treatment of AML. The purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with azacitidine and venetoclax for subjects with newly diagnosed and relapsed /refractory AML.

Key Dates

Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
112 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aclarubicin + Venetoclax + Azacitidine
    Aclarubicin will be used in a dose escalation and dose expansion approach. Venetoclax and aclarubicin will be used in a fixed dose throughout the phases. Phase I dose-escalation: a standard "3+3" approach for aclarubicin. Phase II: Cohort A will enroll patients same as in phase I and Cohort B will enroll patients with relapsed/refractory AML after intensive chemotherapy. Aclarubicin will be used at the dose determined by the dose escalation.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 28 days after first dose of aclarubicin ]

Central Contacts

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