Drug combination for acute myeloid leukemia that came back or resisted treatment
Tests mitoxantrone liposome, cytarabine and venetoclax in hard-to-treat acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose acute myeloid leukemia (AML) has come back or did not respond to earlier treatment. They would get three drugs together: mitoxantrone liposome, cytarabine and venetoclax.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory AML (leukemia that came back or did not respond), not acute promyelocytic leukemia. This includes people who failed at least 1 course of first treatment, or whose leukemia returned after remission, or whose MRD test turned from negative to positive. Also ECOG 0-2 and life expectancy over 3 months.
- Earlier treatment
- Must have had at least 1 course of first (induction) treatment that failed. Cannot have had mitoxantrone or mitoxantrone liposome before. Cannot have had doxorubicin above 360 mg/m^2 in total. Cannot have had other anti-tumor treatment or trial drugs within 4 weeks or 5 half-lives of the drug.
- Biomarker or test result
- Blood tests must show liver and kidney values within set limits: AST/ALT up to 2.5 times the upper limit of normal, total bilirubin up to 1.5 times, serum creatinine up to 1.5 times. HIV, hepatitis B and hepatitis C tests must not show active infection above the limits in the record.
Main reasons for not taking part
- Leukemia in the central nervous system
- Serious heart disease, such as QTc over 480 ms or heart ejection fraction below 50%
- HIV infection
- Pregnant or breastfeeding women, or refusing effective contraception
- Other cancer now or before, with some listed exceptions
Read by machine on 12 November 2026.
Where in China
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Jie JinTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- First Affiliated Hospital of Zhejiang University
- Trial code
- NCT06621212
- Record updated
- 16 September 2025
- Original description
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.Read full original descriptionShow less
A Prospective, Multi-center, Phase 2 Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Standard-dose Cytarabine and Venetoclax in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
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.
Inclusion: Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study; Age ≥18; Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia; Patients who failed after at least 1 courses of initial induction therapy; Bone marrow blasts≥5% after CR/CRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leukemia cell infiltration appeared in extramedullary; Conversion from MRD negativity to MRD positivity after CR/CRi; Physical status score of Eastern Oncology Collaboration Group (ECOG) 0-2; Life expectancy > 3 months; AST/ALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.
Exclusion: Previous anti-tumor therapy meets one of the following criteria:; Prior therapy with mitoxantrone or mitoxantrone liposome; Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin > 360 mg/m\^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin); Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study; Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment; Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years); Subjects who are unable to take oral medications or have malabsorption syndrome; Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection); HIV infection; HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; or HCV-RNA≥1x10\^3 copies/mL; A history of immediate or delayed allergy to similar drug and excipients of the investigate drug; With a history of severe neurological or psychiatric illness; Cardiovascular diseases, including but not limited to:; QTc interval >480 ms or long QTc syndrome in screening; Complete left bundle branch block, 2 or 3 grade atrioventricular block; Requiring treatment of serious and uncontrolled arrhythmia; New York Heart Association NYHA≥2; Cardiac ejection fraction (EF) was less than 50%; Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities; Central nervous system leukemia; Pregnant, lactating female or subjects who refuse to use effective contraception during the study; Not suitable for this study as decided by the investigator.