acute myeloid leukemia
Conditions
Interventions
Treatment Group:a quadruple combination regimen (venetoclax, azacitidine, homoharringtonine, cytarabine)
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with acute myeloid leukemia in accordance with the WHO-2022 classification system; and meeting the definition of refractory or relapsed AML.The definition of refractory AML: After one course of treatment, no composite complete remission (CRc) is achieved and the reduction of bone marrow blasts is less than 50%, or CRc is not achieved after two courses of treatment. The definition of relapsed AML: After achieving CRc, peripheral blood blasts reappear, or bone marrow blasts are >= 5%, or extramedullary lesions occur. 2.Age >= 18 years; expected survival time >= 3 months; 3.ECOG score 0-2; 4.Women of childbearing potential must have a negative pregnancy test and be willing to use effective contraception during the study period and for >=12 months after the last dose. Male participants must use effective contraception during the study period and for >=3 months after the last dose; 5.Intact hepatic and renal function (creatinine <= 1.5 × ULN, BUN <= 1.5 × ULN, ALT <= 2 × ULN, AST <= 2 × ULN, total bilirubin <= 1.5 × ULN). 6.Voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Previously received allogeneic hematopoietic stem cell transplantation; 2. Acute promyelocytic leukemia (M3); 3. Central nervous system leukemia; 4. Combined with other malignant tumors within 5 years; 5. Active viral or bacterial infection that cannot be controlled with appropriate anti-infective treatment; 6. Known seropositive reaction for HIV; 7. Patients with mental disorders or other conditions unable to cooperate with the requirements of research treatment and monitoring; 8. Patients with uncontrolled heart disease; 9. Bone marrow fibrosis grade 2-3; 10. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission rate(CRc); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR);Myelosuppression;Disease free survival;Cytogenetic Response;Overall Response Rate (ORR);Partial Response (PR);Treatment-Related Infection;Gastrointestinal Toxicity;MRD negative rate;Event free survival;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactHongyan Tong
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed