Actively Recruiting
Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-16
72
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
C
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 72 R/R AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
CONDITIONS
Official Title
Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form indicating understanding and willingness to participate
- Age 18 years or older
- Clinically diagnosed relapsed or refractory AML, excluding acute promyelocytic leukemia
- Failed at least one course of initial induction therapy or have at least 5% bone marrow blasts after remission, or reappearance of blasts in blood, or leukemia cell infiltration outside bone marrow
- Eastern Oncology Collaboration Group (ECOG) performance status score of 0 to 2
- Life expectancy greater than 3 months
- Liver enzymes AST/ALT no more than 2.5 times the upper limit of normal (ULN), or up to 5 times ULN if hepatic infiltration is present
- Total bilirubin no more than 1.5 times ULN, or up to 3 times ULN if hepatic infiltration is present
- Serum creatinine no more than 1.5 times ULN
You will not qualify if you...
- Prior therapy with mitoxantrone or mitoxantrone liposome
- Prior therapy with doxorubicin or anthracyclines exceeding a cumulative dose of 360 mg/m^2 doxorubicin equivalent
- Received other anti-tumor therapies or clinical trial drugs within 4 weeks or five half-lives before the study
- Use of strong or moderate CYP3A inducers/inhibitors or P-glycoprotein inhibitors within 7 days before starting treatment
- Inability to take oral medications or presence of malabsorption syndrome
- Cardiovascular conditions including QTc interval over 480 ms, certain heart blocks, serious arrhythmias, NYHA class 2 or higher heart failure, ejection fraction below 50%, recent heart attacks or unstable angina
- Central nervous system leukemia
- Previous or current other malignancies except certain well-controlled skin or cervical cancers
- Uncontrolled diseases such as diabetes, hypertension, or advanced infections
- HIV infection
- Positive for hepatitis B or C with specified viral loads
- History of allergic reaction to study drugs or their components
- Pregnant or breastfeeding women or those refusing contraception
- History of severe neurological or psychiatric illness
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jie Jin, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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