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To compare the efficacy and safety of low-dose venetoclax combined with azole and full-dose venetoclax without azole in the treatment of newly diagnosed AML patients who are intolerant to intensive chemotherapy

To compare the efficacy and safety of low-dose venetoclax combined with azole and full-dose venetoclax without azole in the treatment of newly diagnosed AML patients who are intolerant to intensive chemotherapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087406
Enrollment
Unknown
Registered
2024-07-26
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Acute myeloid leukemia

Interventions

trial group:Low-dose venetoclax group (venetoclax 100-200mg/d, d1-28), combined with azole antifungal drugs (voriconazole, posaconazole, itraconazole, esaconazole and fluconazole, etc.)
Control group:The other group was full dose venetoclax (full dose group, not combined with azole antifungal drugs 100mg/d on the first day, 200mg/d on the second day, 400mg/d on the third day and ther

Sponsors

The First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: Treatment-naive patients with AML who could not tolerate intensive chemotherapy were eligible for the protocol. 1. Definitive diagnosis of AML by MICM typing (excluding acute promyelocytic leukemia Disease M3); 2 over 14 years of age, regardless of gender or race; 3. Physical status: ECOG score 0-3; 4. Cardiac function: left ventricular ejection fraction = 40%; 5. Expected survival time > 12 weeks; 6. Serum creatinine (Cr) =1.5×ULN (upper limit of normal), alanine aminotransferase (ALT) Aspartate aminotransferase (AST) =2.5×ULN, total bilirubin =1.5×ULN; 7. The patient is self-aware and able to sign informed consent; The guardian of the child patient provided consent Informed consent was obtained.

Exclusion criteria

Exclusion criteria: 1. Except for secondary AML; 2. pregnant or lactating women; 3. active HBV or HCV infection; 4. People living with HIV;

Design outcomes

Primary

MeasureTime frame
Complete response Rate;

Secondary

MeasureTime frame
The incidence of adverse effects;

Countries

China

Contacts

Public ContactJuan Tong

The First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)

tongj5200@163.com+86 139 5511 4442

Outcome results

None listed

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