Acute Myeloid Leukemia(AML)
Conditions
Interventions
Group 1:Palbociclib combined with azacitidine/Venetoclax:
Subcutaneous injection of azacitidine 75 mg/m2 on days 1-7
Venetoclax 100 mg orally on day 1
200mg on day 2
400mg on days 3-28
Oral administration of pebociclib 100mg/ pill, 100mg each time, once a day, from day 1 to day 21
The principle of dose adjustment of venetoclax and papbociclib: according to the bone marrow suppression and the combined use of CYP3A inhibitors, the investigators adjusted the dose according to the
Sponsors
The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
14 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. AML patients aged over 60 years, or younger than 60 years and older than 14 years who were unfit for intensive chemotherapy, regardless of sex or race. (2) All patients were diagnosed as non-M3 acute myeloid leukemia by MICM classification (WHO 2016 criteria). Karnofsky score =60% and Eastern Cooperative Oncology Group (ECOG) performance status score 0-2; 3. (4) Serum total bilirubin = 1.5 times the upper limit of normal (upper limit of normal for the same age) within 2 weeks before enrollment; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 times the upper limit of normal (for the same age); Serum creatinine = 2 times the upper limit of normal (for the same age); Myocardial enzymes < 2 times the upper limit of normal; 5. Anti-hiv test negative; 6. Each subject must sign an informed consent Form (ICF) indicating that he/she understands the purpose and procedures of the study and is willing to participate in the study; Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal representative will sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with a CDK4/6 protein inhibitor; 2. Had a history of severe allergy to azacitidine and venetoclax; 3. Patients who participated in a clinical trial in the past 3 months; 4. Patients receiving allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 5. Participants with New York Heart Association (NYHA) class 3 or 4 congestive heart failure or a prior history of NYHA class 3 or 4 congestive heart failure were not allowed to participate unless their left ventricular ejection fraction (LVEF) was =45% on screening echocardiography performed within 1 month before study entry. 6. Use of a strong or moderate cytochrome P450 (CYP) 3A inducer within 7 days before initiation of treatment; 7. Consumption of grapefruit, grapefruit products, limes (including marmalade containing lime), or star fruit within 3 days before starting study treatment; 8. Anti-hiv test positive; 9. Pregnant or lactating women; 10. Mental illness that may prevent the subject from completing the treatment or prevent informed consent; 11. The subject has evidence of other clinically significant, poorly controlled systemic infection (viral, bacterial or fungal) requiring treatment; 12. Nonadherence and other conditions deemed by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Countries
Chaina
Contacts
Public Contactanyou Wang
The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Outcome results
None listed