Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, Bcl-2 Inhibitors, Azacytidine, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;
- Participants are ineligible for induction regimen;
- The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
- The patients and their families agree and sign the informed consent form.
Exclusion Criteria:
- Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);
- Infiltration of the central nervous system;
- Drugs use history affecting CYP3A within 7 days before enrollment;
- participants considered by the investigator to be unsuitable for inclusion.
Sites / Locations
- Long ZhaoRecruiting
Arms of the Study
Arm 1
Experimental
Venetoclax group
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative. regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2,the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.