Acute myeloid leukemia
Conditions
Interventions
experimental group:Azacitidine
Sponsors
The First Afflilated Hospital, Collegue of Medicine, College of medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 60 years; expected survival time >= 1 year; 2. Patients diagnosed with AML (except APL, including MDS-RAEBII-AML) according to the WHO (2016) classification system, achieved CR / CRi after 1-2 courses of induction chemotherapy; 3. After two courses of consolidation chemotherapy, within 30 days before enrollment, the patient is still in CR / CRi status after blood cell count, bone marrow examination and cytogenetic examination; 4. ECOG score 0-2; 5. Neutrophils >= 0.5 * 10^9 / L, platelets >= 50 * 10^9 / L; healthy liver and kidney function (creatinine <= 1.5 * ULN, BUN <= 1.5 * ULN, ALT <= 2 * ULN, AST <= 2 * ULN, Total bilirubin <= 1.5 * ULN); 6. Female subjects who may be pregnant agree to use a physician-approved contraceptive during the use of azacitidine, and within 1 month after the last dose of azacitidine (oral, injectable, or implanted sex hormone contraceptives; fallopian tube ligationcontraceptive ring; barrier contraceptive combined with spermicidal drugs; or vas deferens for sexual partners); and a negative pregnancy test within 72 hours before starting the test drug; male subjects who may be pregnant with a female partner must be throughout the study period Agree to use a physician-approved method of contraception and to avoid conceiving a female partner throughout the study period and within 2 months after the last dose of azacitidine; 7. The patient voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received a hematopoietic stem cell transplant in the past year, or have recently received a hematopoietic stem cell transplant plan; 2. AML with extramedullary invasion (including central nervous system leukemia), CML, MPN, APL patients; 3. Patients with previous methylation drugs, including decitabine and azacitidine; 4. Patients received other chemotherapy drugs (except basic supportive treatment drugs) within 30 days before the first day of cycle 1, including cytarabine, daunorubicin, epirubicin and homoharringtonine; 5. Participants in other clinical trials within 30 days; 6. Have a history of cancer and have received any treatment for this tumor in the past 3 years, except for the removal of superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial cancer (CIN), "Breast Cancer" or Prostate Intraepithelial Carcinoma (PIN); or other local malignant tumors with a high probability of cure by surgical resection or radiation therapy; 7. Active viral or bacterial infections that cannot be controlled with appropriate anti-infective treatment; 8. Known as positive serological response to HIV; 9. Suffering from mental illness or other conditions that do not fit the requirements of research treatment and monitoring; 10. Patients with uncontrolled heart or other medical conditions; 11. Patients known to be allergic to azacitidine; 12. The investigator assesses that there are other conditions which are inappropriate for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Adverse event; | — |
Countries
China
Contacts
Public ContactTong Hongyan
The First Afflilated Hospital, Collegue of Medicine, Zhejiang University
Outcome results
None listed