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

Clinical observation for the treatment of acute myeloid leukemia in the elderly with chidamide combined with desitabine

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026419
Enrollment
Unknown
Registered
2019-10-09
Start date
2019-10-08
Completion date
Unknown
Last updated
2019-10-14

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:Desitabine combined with chidamide

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;

Secondary

MeasureTime frame
progression free survival;

Countries

China

Contacts

Public ContactYinghua Li

The First Affiliated Hospital of Harbin Medical University

yinghualihmu@126.com+86 0451-85555255

Outcome results

None listed

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