Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
20mg/m2/d x5 days (induction \& consolidation)
400mg/d x14 days (induction); 400mg/d x7 days (consolidation)
Dose escalation, given on Days 1 and 15 of each cycle
Northside Hospital, Inc.
Atlanta, Georgia, United States
Phase 2 Dose Level determination
To find the recommended phase 2 dose (RP2D) of axatilimab when combined with decitabine and venetoclax by recording adverse events based on the CTCAE v.5.
Time frame: 1 year
Estimation of MRD-negative complete remission
To estimate the MRD-negative complete remission rate after 1-2 cycles of induction chemotherapy with decitabine and venetoclax by conducing bone marrow biopsies and disease response assessments after induction
Time frame: 2 months
Estimation of Response Rates, Overall Survival
To estimate the complete response rate by evaluating bone marrow biopsies that occur after induction and every 3 months during consolidation
Time frame: 1 year
Evaluation of Safety of the Regimen
To evaluate the safety and tolerability of axatilimab when combined with decitabine and venetoclax by recording all adverse events according to the CTCAE v5.0
Time frame: 1 year
Estimation of Progression Free Survival
To estimate the progression free survival rate by evaluating bone marrow biopsies that occur after induction and every 3 months during consolidation
Time frame: 1 year
Estimation of Overall Survival
To estimate the overall survival rates by contacting patients 1 year after completion of therapy for survival data
Time frame: 1 year
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