Acute Myeloid Leukemia Clinical Trial
Official title:
A Prospective Randomized Controlled Clinical Study of Bortezomib Combined With DAG Regimen in the Treatment of Refractory/Relapsed AML
In recent years, the efficacy of AML has been greatly improved, which is mainly due to the following aspects: the development of individualized treatment strategies based on genetic prognosis stratification, the application of high-dose cytarabine-containing induction and consolidation regimens , the choice of allogeneic or autologous hematopoietic stem cell transplantation, etc. However, 20%-30% of young patients and 40%-50% of elderly patients will relapse again, and 20%-40% of patients cannot be relieved after standard induction regimens, that is, relapsed and refractory AML. The re-induction remission rate is low, the survival period is short, and the prognosis is extremely poor. There is still a lack of standard treatment options. Although a small number of patients can benefit from allogeneic hematopoietic stem cell transplantation (allo-HSCT), most patients lack suitable donors. The choice of high-dose chemotherapy is a salvage treatment option, but treatment-related hematological or non-hematological toxicities and high lethality make the option controversial, especially for the elderly. The development of new low-toxic targeted drugs is a future trend, and the design of new efficient and safe chemotherapy regimens is also a way of thinking. This study designed a prospective single-center clinical randomized controlled study plan, that is, the use of bortezomib (1.3mg/m2, d1, 4, 8, 11) combined with DAG regimen in the treatment of refractory/relapsed AML, to evaluate the clinical efficacy (complete remission rate , total effective rate, 2-year progression-free survival rate and 2-year overall survival rate), and observe how safe the new program is. The results of the research will make it possible to design a high-efficiency, low-toxicity and high-feasibility chemotherapy regimen for refractory/relapsed patients, and guide the clinical treatment of relapsed/refractory acute leukemia.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients diagnosed with AML confirmed by bone marrow morphology and immunology 2. Patients who do not respond or relapse after conventional treatment 3. Age 18-75 4. Liver and kidney function: blood bilirubin = 35 µmol/L, AST/ALT below 2 times the upper limit of normal value, 451 µmol/L = serum creatinine = 133 µmol/L, 80 ml/min = creatinine clearance = 20ml/min 5. Cardiac function index EF value = 50% 6. Physical condition score 0-2 (ECOG score) 7. Obtain signed informed consent from patients or family members Exclusion Criteria: 1. Allergies or obvious contraindications to any of the drugs involved in the program 2. Severe heart disease, including myocardial infarction and cardiac insufficiency. 3. Suffering from other organ malignancies at the same time 4. Active tuberculosis patients and HIV positive patients 5. Suffering from other blood system diseases at the same time 6. Pregnant or lactating women 7. Inability to understand or follow the research protocol 1. Past history of intolerance or allergy to similar drugs 2. Patients under 18 years old or over 75 years old 3. Simultaneously participate in other clinical investigators 4. Any other circumstances that prevent the conduct of the study |
Country | Name | City | State |
---|---|---|---|
China | Zhongnan Hospital of Wuhan University | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Zhongnan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate Rate of bone marrow blasts | Bone marrow blasts <20% | Evaluation at the 4th weekend after the end of all chemotherapy cycles | |
Secondary | blood routine | differential blood count | Evaluation at the 4th weekend after the end of all chemotherapy cycles | |
Secondary | liver function | Detection of hepatic metabolite concentration in blood | Evaluation at the 4th weekend after the end of all chemotherapy cycles | |
Secondary | Recovery time | Recovery time of patients' neutrophils, hemoglobin and platelets | Evaluation at the 4th weekend after the end of all chemotherapy cycles | |
Secondary | The incidence of complications in patients | The incidence of complications in patients | Evaluation at the 4th weekend after the end of all chemotherapy cycles | |
Secondary | kidney function | Urine composition analysis | Evaluation at the 4th weekend after the end of all chemotherapy cycles |
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