Actively Recruiting
Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-05-30
34
Participants Needed
1
Research Sites
117 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 goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
CONDITIONS
Official Title
Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With 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
- Patients who failed after 2 courses of standard treatment
- Bone marrow blasts 5% or more after first complete remission or reappearance of blasts in blood in at least 2 samples one week apart, or extramedullary leukemia infiltration without treatment
- First change from minimal residual disease negativity to positivity without treatment
- Eastern Oncology Collaboration Group (ECOG) performance status 0 to 2
- Ability to tolerate intensive chemotherapy as determined by researchers
- Life expectancy greater than 3 months
- Liver and kidney function within specified limits: AST/ALT ≤ 2.5 times upper limit of normal, total bilirubin ≤ 1.5 times upper limit of normal, serum creatinine ≤ 1.5 times upper limit of normal
You will not qualify if you...
- Previous treatment with mitoxantrone or mitoxantrone liposome
- Prior therapy with doxorubicin or anthracyclines exceeding cumulative dose of 360 mg/m2
- Received other anti-tumor therapy or clinical trial drugs within 4 weeks or 5 half-lives before study
- Cardiovascular conditions including QTc interval >480 ms, long QTc syndrome, complete left bundle branch block, grade 2 or 3 atrioventricular block, serious uncontrolled arrhythmia, NYHA class 3 or higher heart failure, ejection fraction below 50%, recent serious cardiac events or conduction abnormalities
- Central nervous system leukemia
- Other malignancies within past 5 years except certain effectively controlled cancers
- Uncontrolled diseases such as diabetes, hypertension, or severe infections
- HIV infection
- Positive hepatitis B or C markers with high viral load
- History of allergy to study drug or its components
- Pregnant or lactating females or those refusing contraception
- History of severe neurological or psychiatric illness
- Any other condition judged unsuitable by 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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