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Recruiting Phase 2

Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML

NCT06621212 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-07-05
Last updated
2025-09-16

Condition(s) studied

Relapsed/Refractory Acute Myeloid LeukaemiaMyeloid Malignancy

Investigational drug(s) / intervention(s)

mitoxantrone hydrochloride liposome →Cytarabine →Venetoclax →

mitoxantrone hydrochloride liposome: Mitoxantrone hydrochloride liposome (30 mg/m\^2) on day 1, every 4 weeks

Cytarabine: Cytarabine (100 mg/m\^2 ) on day 1-7, every 4 weeks

Venetoclax: Venetoclax 100 mg on day 2,200 mg on day 3,400 mg on day 4-8, every 4 weeks

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Age ≥18 3. Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia. 1. Patients who failed after at least 1 courses of initial induction therapy. 2. 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. 3. Conversion from MRD negativity to MRD positivity after CR/CRi. 4. Physical status score of Eastern Oncology Collaboration Group (ECOG) 0-2. 5. Life expectancy \> 3 months. 6. 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 Criteria: 1. Previous anti-tumor therapy meets one of the following criteria: 1. Prior therapy with mitoxantrone or mitoxantrone liposome; 2. 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); 3. 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; 2. Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment; 3. Subjects who are unable to take oral medications or have malabsorption syndrome; 4. Cardiovascular diseases, including but not limited to: 1. QTc interval \>480 ms or long QTc syndrome in screening; 2. Complete left bundle branch block, 2 or 3 grade atrioventricular block; 3. Requiring treatment of serious and uncontrolled arrhythmia; 4. New York Heart Association NYHA≥2; 5. Cardiac ejection fraction (EF) was less than 50%; 6. 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. 5. Central nervous system leukemia; 6. 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). 7. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection); 8. HIV infection. 9. HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; or HCV-RNA≥1x10\^3 copies/mL; 10. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug. 11. Pregnant, lactating female or subjects who refuse to use effective contraception during the study. 12. With a history of severe neurological or psychiatric illness. 13. Not suitable for this study as decided by the investigator.

Primary outcome measure(s)

  • Composite complete remission (CRc) rate — At the end of each cycle (each cycle is 28 days), up to 2 cycles
    Complete remission plus complete remission with incomplete hematologic recovery (CR+CRi). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06621212 on ClinicalTrials.gov ↗ ← All trials in China