Status:
RECRUITING
Venetoclax Plus CACAG Regimen for Newly Diagnosed 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:
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 the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.
Detailed Description
Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past...
Eligibility Criteria
Inclusion
- Patients who are able to understand and willing to sign the informed consent form (ICF).
- All patients should aged 14 to75 years,no gender limitation.
- Patients who are newly diagnosed with AML(no M3).
- 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 0-2, 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 :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06068621
Start Date
March 1 2023
End Date
August 31 2025
Last Update
July 30 2025
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853