HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL).

NCT07517510 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: GD2H-2026-571
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL)

Keywords

Mixed Phenotype Acute Leukemia(MPAL); homoharringtonine; venetoclax

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission (CRc)

  The rate of composite complete remission including complete remission (CR) and CR with incomplete blood count recovery (CRi)

  At the end of cycle 2 (28 days for a cycle)

Secondary Outcomes (4)

• Complete remission (CR)

  At the end of cycle 2 (28 days for a cycle)

• Overall response rate (ORR)

  At the end of cycle 2 (28 days for a cycle)

• Rate of Measurable residual disease (MRD) negative

  At the end of cycle 2 (28 days for a cycle)

• Adverse events

  At the end of cycle 2 (28 days for a cycle)

Other Outcomes (3)

• Overall survival (OS)

  1 year

• Relapse-Free Survival (RFS)

  1 year

• Duration of Response (DOR)

  1 years

Study Arms (1)

HVA regiment

EXPERIMENTAL

HVA regiment for newly diagnosed MPAL

Drug: HVA

Interventions

HVA DRUG

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.

HVA regiment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF);
• Age ≥18 years;
• Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification.
• 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);
• Expected survival ≥12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• 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;

You may not qualify if:

• Patients who have had or currently have other malignant tumors requiring treatment;
• Patients with central nervous system (CNS) infiltration;
• 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.;
• Patients who cannot take oral medications or have malabsorption syndrome;
• Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients;
• Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study;
• Patients with a history of severe neurological or psychiatric disorders who cannot understand or comply with the study protocol;
• Patients with severe heart disease, such as myocardial infarction, severe or unstable angina, severe arrhythmias;
• 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;
• Patients who cannot take oral medications or have malabsorption syndrome;
• Patients whom the investigator determines are unsuitable to participate in this study.

Sponsors & Collaborators

• Guangdong Second Provincial General Hospital: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Guangzhou First People's Hospital: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Dongguan People's Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Department of Hematology, Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Leukemia, Biphenotypic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)