acute myeloid leukemia
Conditions
Interventions
Experimental group:azacytidine plus low dose venetoclax
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 60 years, male or female; 2. According to the WHO diagnostic criteria in line with AML (non-APL); 3. No uncontrolled current infection (new infection, body temperature is still greater than 38°C after 72 hours of broad-spectrum antibiotics, except for other non-infectious factors); 4. In line with refractory AML, complete remission was not obtained after 2 courses of induction therapy; patients who relapsed within 12 months after the first complete remission; those who relapsed after 12 months after the first complete remission, failed re-treatment with the original regimen 2 or more relapses; persistent extramedullary leukemia; or meet the diagnostic criteria for relapsed AML: reappearance of leukemia cells in peripheral blood or bone marrow blasts > 5% after complete remission (except for other reasons, such as consolidation chemotherapy, bone marrow Reconstruction, etc.); extramedullary infiltration of leukemia cells; 5. Ability to understand and willing to sign the informed consent form for this trial.
Exclusion criteria
Exclusion criteria: 1. Involvement of the central nervous system; 2. Combined with life-threatening or treatment-affecting complications; 3. Severe allergy to azacitidine or veneclair; 4. Those with clinical symptoms of brain dysfunction or severe mental illness who cannot understand or comply with the program; 5. Combined with other malignant tumors who need treatment; 6. According to the judgment of the investigator, the patient has other conditions that are not suitable for inclusion. Patients had any abnormalities (at the investigator's discretion) that were not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission;Complete remission with incomplete blood count recovery;hematological improvement;overall survival;Time to response;Duration of response;Rates of death; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related death;Relapse rate;Adverse events; | — |
Countries
China
Contacts
Public ContactLiu Hui
Beijing Hospital
Outcome results
None listed