Acute Myeloid Leukemia (AML)
Conditions
Brief summary
A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease
Detailed description
This study is a randomized controlled, prospective clinical trial, with the leading unit being the First Hospital of Jilin University. It aims to screen patients with a suboptimal response to chemotherapy based on early peripheral blood minimal residual disease (MRD) levels, and explore the efficacy and safety of adding venetoclax. A total of 70 subjects are expected to be enrolled, with 35 subjects each in the experimental group and the control group. The study will collect data on subjects' demographics, other baseline characteristics, medication usage, prognosis, etc. Statistical analysis will be performed on the collected data to compare efficacy indicators.
Interventions
DRUGVenetoclax
Patients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days.
Sponsors
Yehui Tan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping. 2. Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up. 3. Age ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%. 6. Renal function with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection). 7. Liver function with Aspartate Aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine Aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*Unless considered due to leukemia infiltration). 8. Patients deemed suitable to receive DA/IA therapy by the investigator. 9. Signed informed consent form. -
Exclusion criteria
1. Acute promyelocytic leukemia (APL). 2. Mixed phenotype acute leukemia (MPAL). 3. AML patients with known central nervous system (CNS) involvement. 4. Presence of extramedullary disease (EMD). 5. Significant hepatic or renal dysfunction exceeding the inclusion criteria limits. 6. Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction. 7. Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible). 8. Active tuberculosis or HIV-positive patients. 9. Concurrent other hematological disorders. 10. Pregnant or lactating women. 11. Inability to comprehend or comply with the study protocol. 12. Hypersensitivity to any component of the drugs involved in the protocol. 13. Inability to take oral medication or patients with malabsorption syndrome. 14. Uncontrolled systemic infection. 15. Prior venetoclax treatment and/or current participation in any other study involving investigational agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Composite Complete Response Rate（mCRc） | Through study completion, an average of 1 year | Complete Response（CR） + Complete Response with Incomplete Hematologic Recovery（CRi）+Morphologic Leukemia Free State（MLFS） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months. | Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis. |
| MRD Negative Conversion Rate | Through study completion, an average of 1 year | Defined as the proportion of patients who convert to MRD negative among all evaluable patients for efficacy. |
| Relapse-Free Survival(RFS) | From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months. | Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up |
Countries
China
Contacts
Primary ContactYehui Tan
Backup ContactYuying Li
Outcome results
None listed