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A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial. A total of 320 patients will be enrolled in this study,and segregated into four groups with 80 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
Official title: VISTA-AML- Venetoclax Intensity Selection Trial in AML: A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2026-09-30
Completion Date
2029-09-30
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
Daunorubicin
daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-3,
Cytarabine
Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-7,
Liposome Mitoxantrone
Liposome Mitoxantrone: 24 mg/m², administered by intravenous drip (ivgtt) on day 1,
Venetoclax
Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po),
Azacitidine
Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7,
Venetoclax
Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21, administered orally (po). Bone marrow examination is performed on day 21. If blasts \>5%, then venetoclax 400 mg is continued on days 21-28.
Daunorubicin
daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-2,
Cytarabine
Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-5,
Venetoclax
Venetoclax: 100 mg on day 3, 200 mg on day 4, and 400 mg on days 5-11, administered orally (po),