Clinical research for azacitidine combined with low-dose dasatinib in maintenance treatment of Acute Myeloid Leukemia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042418

Enrollment

Unknown

Registered

2021-01-21

Start date

2021-04-20

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

acute myeloid leukemia

Interventions

experimental group:Azacitidine combined with low-dose dasatinib

control group:Azacitidine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients with intermediate and high-risk AML who are diagnosed according to the 2016 WHO guidelines, aged >=18 years; 2) Detect minimal residual disease(-) after induction therapy and intensive consolidation therapy; 3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2; 4) The heart, pulmonary, liver and kidneys have sufficient organ functions: a) Cardiac color doppler ultrasound shows cardiac ejection fraction> 50%, heart function classification NYHA III/IV, no heart block or arrhythmia; b) Patients without severe restrictive/obstructive pulmonary disease; c) Liver function: total bilirubin (TBIL) < 2 times the upper limit of normal, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <2.5 times the upper limit of normal; d) Renal function: serum creatinine (Cr) < 1.5 times the upper limit of normal. 5) The patient and family members agree and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with malignant tumors of other organs; 2) HCV positive; or HIV positive; or one of the following HBV test results: a) HBsAg positive; b) HBsAg negative, HBcAb positive and HBV DNA titer positive; 3) Pregnant and lactating women, and patients who have family planning during the enrollment period; 4) Patients considered to be unsuitable for enrollment by the investigator.

Design outcomes

Primary

Measure	Time frame
overall survival;disease-free survival;	—

Secondary

Measure	Time frame
rates of death;recurrence rate;Blood routine;Liver and kidney function; coagulation function;Ion test;Bone marrow cell morphology;Bone marrow biopsy;	—

Countries

China

Contacts

Public ContactLiu Bei

The First Hospital of Lanzhou University

liubeiff@163.com+86 13809319379

Outcome results

None listed

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