Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML
NCT05264883 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2023-05-30
Summary
This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia.
This study involves the following:
Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)
Conditions
Interventions
- DRUG
-
Venetoclax-Decitabine/Azacitidine-Aclarubicin Association
Treatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin
- DRUG
-
Venetoclax-Decitabine/Azacitidine Association
Treatment with Venetoclax+Decitabine/Azacitidine
Sponsors & Collaborators
-
The Affiliated Jiangning Hospital of Nanjing Medical University
collaborator OTHER -
Huai'an First People's Hospital
collaborator OTHER -
Yancheng First People's Hospital
collaborator OTHER -
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-01
- Primary Completion
- 2023-06-28
- Completion
- 2025-02-28
Countries
- China
Study Locations
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