Skip to content

Clinical observation for the treatment of acute myeloid leukemia in aged patients with citabine combined with cytarabine

Chidamide combined with azacitidine treating acute myeloid leukemia in the elderly: a single-center, single-arm, open and prospective clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026796
Enrollment
Unknown
Registered
2019-10-22
Start date
2019-10-31
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Acute myeloid leukemia

Interventions

single arm:citabine combined with azacitidine

Sponsors

The First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) aged 55 years, male or female; 2) acute myeloid leukemia was first diagnosed according to the classification of myeloid tumors and acute leukemia revised by the world health organization (WHO) in 2016; 3) ECOG behavior status score is 0-3; 4) expected survival time >= 3 months; 5) no serious heart, lung, liver or kidney diseases; 6) did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment; 7) ability to understand and be willing to sign the informed consent for this test.

Exclusion criteria

Exclusion criteria: 1) previous allergy to drugs included in the test protocol or to drugs with similar chemical structure to the tested drugs; 2) pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 3) active infection; 4) patients who take drugs or drink excessively for a long time and thus affect the evaluation of test results; 5) patients suffering from mental disorders or other conditions cannot obtain informed consent and cannot cooperate with the requirements of completing the experimental treatment and examination procedures; 6) have clinical significance in patients with a history of QTc duration between (men > 450 ms, women >470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), the above II degrees heart block, the onset of myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and symptomatic drug treatment of patients with coronary heart disease; 7) patients whose b-mode ultrasound showed the width of fluid dark area in the pericardial cavity at the end of diastole >= 10mm; 8) patients receiving organ transplantation; 9) patients with new thrombosis, embolism, cerebral hemorrhage or other diseases or medical history within the last month; 10) less than 6 weeks after major organ surgery; 11) the investigator determines that the participant is not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Countries

China

Contacts

Public ContactYinghua Li

The First Affiliated Hospital of Harbin Medical University

liyinghua1965@aliyun.com+86 0451-8555255

Outcome results

None listed

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