Last updated: April 7, 2024
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting
Phase
2/3
Condition
Acute Myeloid Leukemia
Leukemia
Platelet Disorders
Treatment
Venetoclax Oral Tablet
Daunorubicin
Clinical Study ID
NCT05939180
Victor AML-1
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Gender: female or male.
- Age:18-64 years old.
- Patients with newly diagnosed AML according to the WHO 2022 classification.
- AML patients with adverse risk features according to the 2022 European Leukemia Netrisk stratification.
- Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose <1.0g arepermitted).
- ECOG: 0-2.
- Adequate liver function: Total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartateaminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); alanineaminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN) .
- Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min.
- Be able to understand and be willing to participate in the study. Be able to providewritten informed consent.
Exclusion
Exclusion Criteria:
- Patients with acute promyeloid leukemia.
- AML with central nervous system infiltration.
- Patients diagnosed with myeloid sarcoma.
- Patients have AML secondary to MDS and previously been treated with hypomethylatingagents.
- Patients with active infection, which is considered as uncontrollable by theinvestigator.
- Patients with active hepatitis B, hepatitis C and HIV infection.
- Patients with heart failure (grade 3-4);
- Patients who are pregnant or breastfeeding.
- Patients who refused to be enrolled in the study. Patients who are considered asineligible for the enrollment by the investigators.
Study Design
Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Venetoclax Oral Tablet
Phase: 2/3
Study Start date:
April 01, 2024
Estimated Completion Date:
October 01, 2027
Study Description
Connect with a study center
Ethical Committee of the First Affliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu 215000
ChinaActive - Recruiting
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