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To assess the safety and efficacy of homoharringtonine, cytarabine, and G-CSF in combination with venetoclax (HAGV) in the treatment of childhood acute myeloid leukemia

To assess the safety and efficacy of homoharringtonine, cytarabine, and G-CSF in combination with venetoclax (HAGV) in the treatment of childhood acute myeloid leukemia

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064901
Enrollment
Unknown
Registered
2022-10-21
Start date
2022-10-21
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Initial acute myeloid leukemia

Interventions

None listed

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients or their guardians voluntarily sign the informed consent and are expected to complete the follow-up examination and treatment of the research procedure; 2. According to the MICM type, the participants meet the diagnosis of de novo AML; 3. The organ function is good and meets the following laboratory indicators: direct bilirubin = 60 mL/min/1.73m2; left ventricular ejection fraction (LVEF) >= 45%, or shortened fraction >= 25%; 4. Patients must be between 1 and 18 years old, willing to receive treatment, or within 3 years after completion of treatment; 5. For patients > 16 years old, Karnofsky physical status >= 50 points; for patients <= 16 years old, Lansky functional status is not less than 50 points.

Exclusion criteria

Exclusion criteria: 1. Known to have allergic reactions to any ingredients used in the treatment of this study; 2. Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia or bone marrow failure syndrome are not eligible; 3. Uncontrollable systemic infection; 4. Patients with gastrointestinal dysfunction or gastrointestinal diseases are not included in this study because they may affect the absorption of venetoclax.

Design outcomes

Primary

MeasureTime frame
dose limiting toxicity;

Secondary

MeasureTime frame
complete remission rate;partial response rate;Event-free survival;overall survival;Cumulative recurrence rate;

Countries

China

Contacts

Public ContactHu Shaoyan

Children's Hospital of Soochow University

hushaoyan@suda.edu.cn+86 512 80692929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026