Status:
UNKNOWN
Bortezomib Combined With DAG Regimen in the Treatment of Refractory/Relapsed AML
Lead Sponsor:
Zhongnan Hospital
Conditions:
Bortezomib
Acute Myeloid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 stratifi...
Detailed Description
This study aimed to evaluate the clinical efficacy of bortezomib combined with DAG regimen in the treatment of refractory and relapsed AML (complete remission rate, overall effective rate, 2-year prog...
Eligibility Criteria
Inclusion
- Patients diagnosed with AML confirmed by bone marrow morphology and immunology
- Patients who do not respond or relapse after conventional treatment
- Age 18-75
- 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
- Cardiac function index EF value ≥ 50%
- Physical condition score 0-2 (ECOG score)
- Obtain signed informed consent from patients or family members
Exclusion
- Allergies or obvious contraindications to any of the drugs involved in the program
- Severe heart disease, including myocardial infarction and cardiac insufficiency.
- Suffering from other organ malignancies at the same time
- Active tuberculosis patients and HIV positive patients
- Suffering from other blood system diseases at the same time
- Pregnant or lactating women
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05982756
Start Date
January 1 2020
End Date
December 1 2023
Last Update
August 9 2023
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071