Status:
RECRUITING
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
First Affiliated Hospital of Harbin Medical University
Yantai Yuhuangding Hospital
Conditions:
Acute Myeloid Leukemia
First Line Therapy
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 the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or hi...
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
- Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution
Exclusion
- Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)
- \-
Key Trial Info
Start Date :
April 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06928376
Start Date
April 18 2024
End Date
October 18 2026
Last Update
April 22 2025
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853