Clinical Trial Protocol for the Combined Use of Azacitidine, Venetoclax, and Granulocyte Colony-Stimulating Factor in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) (Phase IIb, Single-arm, Prospective, Single-center Study)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a clinical efficacy study evaluating the VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML). The main objectives of the study are to assess the efficacy and safety of the VAG regimen and to explore the synergistic mechanisms of VAG in combating AML.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age between 18 and 75 years, regardless of gender.
• Diagnosis of AML (excluding APL) according to the 2022 World Health Organization (WHO) diagnostic criteria.
• ECOG performance status of 0-2.
• For female participants of childbearing potential or male participants with female partners of childbearing potential, effective contraceptive measures must be taken throughout the entire treatment period and for 6 months after the treatment period.
• Expected survival of at least 3 months.
• Ability to understand and willingness to participate in the study, and signing an informed consent form.
Locations
Other Locations
China
Huai'an Second People's Hospital
RECRUITING
Huai'an
Contact Information
Primary
Xiaotian Yang
15695110492@163.com
15695110492
Time Frame
Start Date:2021-11-03
Estimated Completion Date:2028-07-31
Participants
Target number of participants:50
Treatments
Experimental: VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML)
AZA: 75mg/m2 on days 1-7 VEN: 100mg on day 1, 200mg on day 2, 400mg on days 3-28 G-CSF: 50-600ug/day, starting on day 1 (adjusted based on WBC count of 10-25\*10E9/L)~In the induction phase of the ND-AML treatment protocol, VEN+AZA+G-CSF is administered. At the end of the induction phase, the efficacy is evaluated. If the patient achieves complete remission (CR), the original treatment protocol is continued for consolidation. If the patient achieves partial remission (PR), the original treatment protocol is repeated for induction until the patient achieves CR or shows no response (NR), progressive disease (PD), or relapse (PR/NR/PD). If the patient shows no response or progressive disease, the study is concluded.