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Alternating treatment of venetoclax plus azacytidine (VA) with azacytidine plus homoharringtonine, low-dose cytarabine, and granulocyte-stimulating factor (AZA+HAG) in elderly patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy: a multicenter, single-arm, phase 2 trial

Alternating treatment of venetoclax plus azacytidine (VA) with azacytidine plus homoharringtonine, low-dose cytarabine, and granulocyte-stimulating factor (AZA+HAG) in elderly patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy: a multicenter, single-arm, phase 2 trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094653
Enrollment
Unknown
Registered
2024-12-25
Start date
2024-04-19
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

acute myeloid leukemia

Interventions

treatment group:Alternate treatment with VA and AZA+HAG regimen

Sponsors

Shenzhen second people‘s hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Newly diagnosed AML patients; 3. Meet the criteria of not suitable for intensive chemotherapy: if the patient is >=60 years old, the patient is considered not suitable for intensive chemotherapy; If the patient is less than 60 years of age, but is not considered appropriate for intensive chemotherapy, including: (a) a lung infection requiring treatment; (b) Hepatic insufficiency (total bilirubin >=2 times the upper limit of normal [ULN] or alanine aminotransferase or aspartate aminotransferase >=2 times the ULN); (c) Renal insufficiency (creatinine >=2×ULN or creatinine clearance =2. 4. Patients who agree to sign and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors; 2. Immunomodulatory therapy, demethylation drugs, chemotherapy and other treatments within 3 months; 3. Patients with a history of severe heart disease; 4. Patients with severe liver and kidney dysfunction; 5. Patients with unclear consciousness or mental disorders can not cooperate with diagnosis and treatment; 6. Allergic to therapeutic drug ingredients; 7. Acute promyelocytic leukemia.

Design outcomes

Primary

MeasureTime frame
composite complete remission rate after 4 cycles;

Secondary

MeasureTime frame
objective response rate (ORR) after 4 cycles;relapsed free survival;overall survival;safety;

Countries

China

Contacts

Public ContactGuangyang Weng

Department of Hematology, Shenzhen Second People's Hospital

laifuzhixin@163.com+86 186 8202 0340

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026