Status:
RECRUITING
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
940 Hospital of the People's Liberation Army Joint Logistic Support Force
The General Hospital of Western Theater Command
Conditions:
Relapsed/Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
14-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Despite advances in therapies for acute myeloid leukemia (AML) in the past decades, some patients still suffer from relapsed/refractory (R/R) disease, resulting in poor outcomes. With a median overall...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06084819
Start Date
August 1 2023
End Date
January 31 2026
Last Update
October 16 2023
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853