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A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
Sponsor: Maxinovel Pty., Ltd.
Summary
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2025-09-05
Completion Date
2027-12-01
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
MAX-40279
Dose escalation:MAX-40279: 40 mg, 50 mg, and 60 mg twice daily (BID). Dose expantion: MAX-40279 RP2D. Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. Azacitidine: 75 mg/m2 days 1-7. 28 days are one cycle.
Azacitidine
Given by IV, 75 mg/m2
Venetoclax
100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.
Locations (1)
Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
Tianjin, China