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A prospective, multicenter, randomized controlled trial for azacytidine combined with half dose of pre excitation in the treatment of senile acute myeloid leukemia

A prospective, multicenter, randomized controlled trial for azacytidine combined with half dose of pre excitation in the treatment of senile acute myeloid leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029213
Enrollment
Unknown
Registered
2020-01-18
Start date
2020-01-18
Completion date
Unknown
Last updated
2020-01-20

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

Conditions

Acute myeloid leukemia

Interventions

Azacytidine + half dose pre excitation group:Azacytidine + half dose pre excitation
Azacytidine:Azacytidine

Sponsors

Taian Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Within 30 days before admission, the diagnosis and typing of newly diagnosed AML patients confirmed by morphology, immunology and genetics were based on the World Health Organization diagnosis standard (who 2018 standard); 2. Aged 60 to 75 years old) male and female; 3. ECoG physical fitness score 0-2; 4. Within 30 days before treatment, the following laboratory indexes were met: 1) total bilirubin <=1.5 ULN; 2) AST and ALT <= 2.5 ULN; 3) creatinine < 2 ULN; 5. No severe center of gravity and pulmonary dysfunction; 6. No central nervous system symptoms; 7. Do not agree to transplant; 8. The informed consent signed by the subjects or their families was obtained. The subjects or their families understood the characteristics of the disease and voluntarily joined the study program for treatment and follow-up.

Exclusion criteria

Exclusion criteria: Subjects who met any of the following criteria could not be enrolled in this study: 1. Severe heart, kidney or liver dysfunction; 2. Patients with other malignant tumors need treatment at the same time; 3. Suffer from other blood system diseases at the same time (such as hemophilia and other researchers think it is not suitable for inclusion); 4. Serious infection or metabolic diseases (including tuberculosis, pulmonary Aspergillus, etc.); 5. There are clinical symptoms of brain dysfunction or serious mental diseases that can not understand or follow the research plan; 6. People who are known to be allergic to azacytidine or any component of chemotherapy drugs 7. Within 21 days of operation with large distance; 8. AIDS patients; 9. Drug abuse, medical, psychological or social conditions that may interfere with subjects' participation in the study or evaluation of the results of the study; 10. Fail to understand or follow the research plan; 11. T (15; 17) (q22; Q12) or T (9; 22) (q34; q11.2) 12. The researchers think it is not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
OS;

Countries

China

Contacts

Public ContactTeng Qingliang

Taian Central Hospital

tatql@163.com+86 13375388422

Outcome results

None listed

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