acute myeloid leukemia
Conditions
Interventions
experimental group:Chidamide+Venetoclax+Azacitidine+MST
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed acute myeloid leukemia (excluding acute promyelocytic leukemia), and cannot use strong induction chemotherapy, acute myeloid leukemia confirmed by bone marrow morphology, histochemistry and immunophenotyping (in line with WHO diagnostic criteria); 2. Aged over 60 years old; 3. ECOG score 0-3; 4. Serum creatinine <= 2.5 mg/dL (unless related to AML); 5. Serum bilirubin <= 2.5 times the upper limit of normal (ULN) (unless AML-related or due to Gilbert syndrome is considered); 6. Alanine transferase (ALT)<=2.5xULN (unless related to AML); 7. The researcher believes that the life expectancy is more than 3 months; 8. Informed and agreed to join the clinical research; 9. Have an available donor; 10. LVEF within the normal range as determined by echocardiography or multiple gated acquisition (MUGA) scans; 11. Donor selection criteria: According to the requirements of peripheral blood hematopoietic stem cell donors, they must be qualified for physical examination, must be able to tolerate the process of blood cell separation and collection, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from serious and/or uncontrollable diseases (such as diabetes, infection, high blood pressure, lung disease, etc.); 2. Patients with severe organ dysfunction; 3. Combined with other cancers; 4. Patients who have received BCL2 inhibitors, demethylating drugs or HDACi treatment in the past; 5. Stroke or intracranial hemorrhage occurred within 6 months before enrollment; 6. Anticoagulation with warfarin or an equivalent vitamin K antagonist (such as phenprocoumarin) is required; 7. Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months prior to screening, or any cardiac function class 3 (moderate) or class 4 ( Severe) heart disease (according to the New York Heart Association functional classification method NYHA); 8. Known history of the following: human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; RNA polymerase chain reaction PCR positive) or active hepatitis B virus (HBV; DNA PCR positive) infection; 9. Any life-threatening disease, physical condition or organ system dysfunction that the investigator believes may compromise the safety of the subject and expose the research results to unnecessary risks; drug dependence; subjects with uncontrolled mental illness; cognitive function handicapped; 10. Donor requirements: HLA matching degree and subject match are: 8-10/10 points match, HIV positive, hepatitis B or C, bone marrow disease, episodic psychosis, poison, drug addiction, suffering from heart disease. Those with vascular diseases considered by the researchers to be unsuitable for peripheral stem cell collection, do not agree to donate stem cells and sign stem cell mobilization collection procedures; 11. Patients judged by other investigators to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| partial response rate;duration of relief;progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactLi Fei
The First Affiliated Hospital of Nanchang University
Outcome results
None listed