Actively Recruiting
A Phase II Study of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine, and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-05-30
34
Participants Needed
1
Research Sites
52 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
Researchers are evaluating a combination treatment of mitoxantrone hydrochloride liposome injection, cytarabine, and venetoclax (called MAV) for adults with relapsed or refractory acute myeloid leukemia (AML). AML is a fast-growing blood cancer with poor outcomes, and current standard treatments often fail or relapse. This phase II study aims to see if the MAV regimen improves complete remission rates and explores how different biological factors relate to treatment success. Participants will receive the MAV treatment in cycles lasting 4 weeks each. The treatment includes mitoxantrone hydrochloride liposome at 24 mg/m2 on day 1, cytarabine at 1.0 g/m2 every 12 hours on days 1, 3, and 5, and venetoclax with increasing doses from 100 mg on day 2 up to 400 mg on days 4 to 10. Up to two cycles of therapy are planned for each participant. During the study, participants will have regular laboratory tests of blood and bone marrow samples to monitor their response and safety. The main outcome measured is the composite complete remission rate after each cycle, with up to two cycles assessed. Secondary outcomes include overall response, relapse-free survival, event-free survival, overall survival up to 12 months, minimal residual disease status, and treatment-emergent side effects. The study includes ongoing monitoring of participant health and treatment effects throughout the treatment period.
CONDITIONS
Brief 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 to participate in the study
- Age 18 years or older
- Clinically diagnosed relapsed or refractory AML, excluding acute promyelocytic leukemia
- Refractory after 2 courses of standard treatment or relapse with bone marrow blasts \u2265 5%, or leukemia cell infiltration without treatment
- Eastern Oncology Collaboration Group (ECOG) physical status score between 0 and 2
- Ability to tolerate intensive chemotherapy as determined by researchers
- Life expectancy longer than 3 months
- Liver enzymes (AST/ALT) \u22642.5 times upper limit of normal (ULN); total bilirubin \u22641.5 ULN; serum creatinine \u22641.5 ULN
You will not qualify if you...
- Prior treatment with mitoxantrone or mitoxantrone liposome
- Prior treatment with doxorubicin or anthracyclines exceeding cumulative dose of 360 mg/m\u00b2
- Received other anti-tumor therapy or clinical trial drugs within 4 weeks or 5 half-lives before study
- Cardiovascular diseases including QTc \u003e480 ms, long QTc syndrome, certain heart blocks, serious arrhythmia, NYHA \u22653, or ejection fraction less than 50%
- Central nervous system leukemia
- Other malignancies except controlled basal cell carcinoma or carcinoma in situ within 5 years
- Uncontrolled diseases including diabetes, hypertension, advanced infection
- HIV infection
- Positive for hepatitis B or C with high viral loads
- History of severe allergy to study drugs or excipients
- Pregnant or lactating females, or unwillingness to use effective contraception
- Severe neurological or psychiatric illness
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks (2 cycles of 4 weeks each)
Participants receive treatment with mitoxantrone hydrochloride liposome, cytarabine, and venetoclax in cycles of 4 weeks. Each cycle includes mitoxantrone hydrochloride liposome on day 1, cytarabine on days 1, 3, and 5, and venetoclax with a dose escalation from day 2 to day 10. Up to 2 cycles of therapy are planned.
Visits during each 4-week cycle corresponding to dosing days and assessments
Duration - Up to 12 months
Participants are monitored for safety and survival outcomes for up to 12 months after treatment.
Periodic visits during follow-up monitoring
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.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here