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Efficacy and Safety of Azacitidine Combined with Low-Dose Cytarabine in Elderly Patients with Previously Untreated Acute Myeloid Leukemia: a Non-Randomised, Open-Label, Multi-Centric, Prospective Study

Efficacy and Safety of Azacitidine Combined with Low-Dose Cytarabine in Elderly Patients with Previously Untreated Acute Myeloid Leukemia: a Non-Randomised, Open-Label, Multi-Centric, Prospective Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035292
Enrollment
Unknown
Registered
2020-08-07
Start date
2020-08-15
Completion date
Unknown
Last updated
2020-08-10

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:Azacitidine Combined with Low-Dose Cytarabine regimen

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed as acute myeloid leukemia by routine examinations such as bone marrow and immunophenotyping according to the 2016 World Health Organization (WHO) classification of AML. 2. Aged >= 65 years. 3. Patients are not suitable for intensive chemotherapy according to the evaluation of the researchers, and must meet >= 1 of the following criteria: (1) ECOG PS >= 3; (2) Charlson comorbidity index (CCI) > 1; (3) Activity of daily living (ADL) <= 60. 4. Patients did not receive any systemic treatment for acute myeloid leukemia before enrolling in the trial. 5. Life expectancy is more than two months. 6. Patients must sign the informed consent form before taking any test related to the trial.

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia. 2. Patients with secondary AML who prior treatment with HMAs for myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). 3. History of malignancy other than acute myeloid leukemia in recent five years. 4. Patients with known human immunodeficiency virus (HIV) infection. 5. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
CR+CRi+MLFS;

Secondary

MeasureTime frame
Overall Survival;Progress-free survival;

Countries

China

Contacts

Public ContactXiujin Ye

The First Affiliated Hospital, College of Medicine, Zhejiang University

yxjsunny@163.com+86 13600519298

Outcome results

None listed

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