Axatilimab + Decitabine/Venetoclax for Acute Myeloid Leukemia

SR
CG
Overseen ByCaitlin Guzowski
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Northside Hospital, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients

Are You a Good Fit for This Trial?

Inclusion Criteria

My cancer has a TP53 gene mutation.
My cancer has a TP53 gene deletion.
My bone marrow test shows positive TP53 staining.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy with decitabine and venetoclax to achieve MRD-negative complete remission

2 months
Bone marrow biopsies and disease response assessments

Consolidation

Participants undergo consolidation therapy with regular bone marrow biopsies every 3 months

1 year
Regular visits every 3 months for bone marrow biopsies

Follow-up

Participants are monitored for safety, overall survival, and progression-free survival

1 year
Contact for survival data 1 year after completion of therapy

What Are the Treatments Tested in This Trial?

Interventions

  • Axatilimab
  • Decitabine
  • Venetoclax

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Axatilimab+Decitabine+VenetoclaxExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northside Hospital, Inc.

Lead Sponsor

Trials
26
Recruited
1,100+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School