The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.
Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
1. azacytidine (75 mg/m2/day, days 1 to 7). 2. cytarabine (75 mg/m2 bid, days 1 to 5). 3. aclamycin (10 mg/m2/day, day1,3,5). 4. Chidamide (30 mg/day , days 0,3). 5. venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ). 6. granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Overall Response Rate (ORR)
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).
Time frame: 1 month after study treatment
Rate of Minimal Residual Disease (MRD)-Negative Response:
Percentage of participants who achieved MRD-negative response, defined as \< 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry or \< 0.01% as assessed by PCR of a bone marrow aspirate.
Time frame: after two courses of chemotherapy (each course is 28 days)
Progression Free Survival (PFS)
PFS was defined as time from the date joining the clinical study to the date of disease progression (PD) or date of death due to any cause, whichever occurred first.
Time frame: 180 days after study treatment
Overall Survival (OS)
Defined as the time from joining the clinical study to death due to any cause.
Time frame: 180 days after study treatment
Rate of Participants With Adverse Events
Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.
Time frame: Through 28 days post last study medication administration
Partial Remission (PR) Rate:
All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent.
Time frame: 1 month after study treatment
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Complete Remission (CR) Rate
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts \&lt;5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \&gt;1.0 x 109/L (1000/µL); platelet count \&gt;100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame: 1 month after study treatment
CR with Incomplete Blood Count Recovery Rate
All CR criteria except for residual neutropenia (\&lt;1.0 x 109/L (1000/µL)) or thrombocytopenia (\&lt;100 x 109/L (100,000/µL)
Time frame: 1 month after study treatment