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NCT Number: NCT07511062

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML

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

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type TP53 Gene Mutation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MDS/AML or AML with a TP53 mutation or deletion, defined as:
  • greater than or equal to 10% AND (one of the following):
  • presence of a TP53 mutation
  • presence of a TP53 deletion by FISH
  • positive TP53 staining on IHC of diagnostic bone marrow
  • Either untreated or first salvage (primary refractory or first relapse)

Exclusion criteria

  • KPS <60
  • active uncontrolled infection
  • history of HIV or active HBV or HBC infection
  • currently active second malignancy
  • calculated CrCl <40mL/min
  • AST and/or ALT and/or direct bilirubin >3x ULN
  • cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias
  • history of acute or chronic pancreatitis, history of myositis
  • known leukemia involvement of CNS
  • hematopoietic stem cell transplantation within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade 2+ related to the transplant
  • active acute or chronic GVHD requiring immunosuppressive treatment

Treatment and study plan

decitabine

Drug

20mg/m2/d x5 days (induction & consolidation)

Venetoclax

Drug

400mg/d x14 days (induction); 400mg/d x7 days (consolidation)

Axatilimab

Drug

Dose escalation, given on Days 1 and 15 of each cycle

Primary outcomes

  1. Phase 2 Dose Level determination

    Time frame: 1 year

    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.

  2. Estimation of MRD-negative complete remission

    Time frame: 2 months

    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

Secondary outcomes

  1. Estimation of Response Rates, Overall Survival

    Time frame: 1 year

    To estimate the complete response rate by evaluating bone marrow biopsies that occur after induction and every 3 months during consolidation

  2. Evaluation of Safety of the Regimen

    Time frame: 1 year

    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

  3. Estimation of Progression Free Survival

    Time frame: 1 year

    To estimate the progression free survival rate by evaluating bone marrow biopsies that occur after induction and every 3 months during consolidation

  4. Estimation of Overall Survival

    Time frame: 1 year

    To estimate the overall survival rates by contacting patients 1 year after completion of therapy for survival data

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Guzowski

CONTACT

[email protected]

404-851-8523

Scott R Solomon, MD

CONTACT

[email protected]

404-255-1930

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Collaborators

  • Incyte Corporation

Registry information

Official study title

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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