HVA: HVA regimen: Venetoclax: 100 mg on day 1, 200 mg on Day 2, 400 mg per day from Day 3 to Day 14; Azacitidine: 75 mg/m2 per day by subcutaneous injection from Day 1 to Day 7; Homoharringtonine : 1mg/m2 per day by intravenous infusion from Day 1 to Day 7. If co-administered with CYP3A inhibitors, the dose of venetoclax was adjusted in accordance with prescribing recommendations. Fms-related receptor tyrosine kinase 3 (FLT3) inhibitors were recommended in patients with FLT3-ITD/TKD mutations. Also tyrosine kinase inhibitors were recommended in patients with BCR/ABL-positive.
Study summary
This study aims to evaluate the safety and efficacy of homoharringtonine combined with venetoclax and azacitidine regimen (HVA) in newly diagnosed MPAL patients, providing a basis for the use of the HVA regimen in the treatment of MPAL.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF);
2. Age ≥18 years;
3. Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification.
4. The patient has not started anti-leukemia treatment after the initial diagnosis (except cytoreductive therapy, such as hydroxyurea or cytarabine \<1.0 g/day or glucocorticoids);
5. Expected survival ≥12 weeks;
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
7. Normal cardiac function, left ventricular ejection fraction ≥50%; normal renal function: creatinine clearance ≥30 ml/min; normal liver function: ALT \<5 times the normal value, bilirubin \<3 times the normal value;
Exclusion Criteria:
1. Patients who have had or currently have other malignant tumors requiring treatment;
2. Patients with central nervous system (CNS) infiltration;
3. Other clinically significant uncontrolled conditions, including but not limited to: (1) uncontrolled or active systemic infections (viral, bacterial, or fungal); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) uncontrolled hypertension, etc.;
4. Patients who cannot take oral medications or have malabsorption syndrome;
5. Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients;
6. Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study;
7. Patients with a history of severe neurological or psychiatric disorders who cannot understand or comply with the study protocol;
8. Patients with severe heart disease, such as myocardial infarction, severe or unstable angina, severe arrhythmias;
9. Patients known to be infected with human immunodeficiency virus (HIV); patients with active hepatitis B or C; subjects who are inactive hepatitis carriers or whose viral hepatitis titers are low after treatment with non-prohibited antiviral drugs are not excluded;
10. Patients who cannot take oral medications or have malabsorption syndrome;
11. Patients whom the investigator determines are unsuitable to participate in this study.
Primary outcome measure(s)
Composite Complete Remission (CRc) — At the end of cycle 2 (28 days for a cycle) The rate of composite complete remission including complete remission (CR) and CR with incomplete blood count recovery (CRi)
Trial sites (1)
Facility
City
Region
Status
Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou
Guangdong
More Guangdong Second Provincial General Hospital trials in China
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.
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