Relapsed/Refractory Acute Myeloid Leukemia Clinical Trial
Official title:
A Prospective,Randomized,and Comparative Study on the Efficacy of Venetoclax Combined With CACAG Regimen and BAT Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 31, 2026 |
Est. primary completion date | January 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients who are able to understand and willing to sign the informed consent form (ICF). - All patients should aged 14 to 75 years,no gender limitation. - Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria - 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 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.) |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital | Air Force Military Medical University, China, First Hospital of China Medical University, People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center, The 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, The General Hospital of Northern Theater Command, The General Hospital of Western Theater Command, Yantai Yuhuangding Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate (ORR) after 1 course of 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).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis. | 1 months after the start of study treatment | |
Secondary | Complete Remission (CR) Rate after 1 course of 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. | 2 months after study treatment | |
Secondary | Complete Remission (CR) Rate after 2 courses of 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. | After two courses of chemotherapy (each course is 28 days) | |
Secondary | Overall Response Rate (ORR) after 2 course of 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).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis. | After two courses of chemotherapy (each course is 28 days) | |
Secondary | 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. | After two courses of chemotherapy (each course is 28 days) | |
Secondary | Event-free survival | Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first. | 180 days after study treatment | |
Secondary | Overall Survival (OS) | Defined as the time from joining the clinical study to death due to any cause. | 180 days after study treatment | |
Secondary | Treatment-related adverse events | Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment. | From the first dose of study treatment to 30 days after the discontinuation of treatment | |
Secondary | Early death | Defined as death within 30 days of chemotherapy. | Within 30 days of the start of the first course of treatment | |
Secondary | Disease-free survival | Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first. | 180 days after study treatment |
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