Acute Myeloid Leukemia
Conditions
Keywords
Venetoclax, CACAG, AML
Brief summary
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.
Detailed description
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.
Interventions
DRUGazacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte
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)
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are able to understand and willing to sign the informed consent form (ICF). * All patients should aged 14 to75 years,no gender limitation. * Patients who are newly diagnosed with AML. * Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal; * Renal function: creatinine ≤the upper limit of normal; * Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; * The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months. * Patients without severe allergic constitution.
Exclusion criteria
* Patients with allergy or contraindication to the study drug; * Female patients who are pregnant or breast-feeding. * Patients with active infection * Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment; * Patients with mental illness or other states unable to comply with the protocol; * Less than 6 weeks after surgical operation of important organs. * Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal; * The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 1 month after study treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 180 days after study treatment | 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. |
| Overall Survival (OS) | 180 days after study treatment | Defined as the time from joining the clinical study to death due to any cause. |
| Rate of Participants With Adverse Events | Through 28 days post last study medication administration | Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration. |
| Rate of Minimal Residual Disease (MRD)-Negative Response: | after two courses of chemotherapy (each course is 28 days) | 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. |
| Complete Remission (CR) Rate | 1 month after study treatment | Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts <5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions. |
| CR with Incomplete Blood Count Recovery Rate | 1 month after study treatment | All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL) |
| Partial Remission (PR) Rate: | 1 month after study treatment | 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. |
Countries
China
Outcome results
None listed