Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients
NCT05471700 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-09-23
Summary
The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.
Conditions
- Leukemia, Myeloid, Acute
Interventions
- DRUG
-
Subjects will receive Azacitidine 75 mg/m2 on days 1-7.Each course is 28 days long.
- DRUG
-
Subjects would receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. Each course is 28 days long.
Sponsors & Collaborators
-
Zhujiang Hospital
lead OTHER
Principal Investigators
-
Yuhua Li, Doctor · Zhujiang Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2023-04-04
- Completion
- 2023-04-04
Countries
- China
Study Locations
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