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Not yet recruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests axatilimab with decitabine and venetoclax for people with AML, a blood cancer, or MDS/AML, a related blood cancer. It is for people whose cancer has a changed or missing TP53 gene or a positive TP53 bone marrow test.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have MDS/AML or AML.
  • Meet a “10% or more” rule. The listing does not say what is being measured.
  • Have a changed TP53 gene, a missing TP53 gene found by a FISH test, or a positive TP53 stain on a bone marrow test.
  • Have not been treated yet, or be starting the first rescue treatment because the first treatment did not work or the cancer came back for the first time.

Who can't join

  • Have a KPS score below 60, which measures how well you can do daily tasks.
  • Have an active infection that is not controlled, a history of HIV, or an active HBV (hepatitis B) or “HBC” infection. The listing does not explain HBC.
  • Have another active cancer, or leukemia in the brain or spinal cord.
  • Have kidney function below 40 mL/min on a CrCl test, or liver blood tests (AST, ALT, or direct bilirubin) over 3 times the upper normal limit.
  • Have a heart pumping level below 40% or a history of heart rhythm problems that are not controlled.
  • Have a history of pancreatitis (swelling of the pancreas) or myositis (swelling of the muscles).
  • Have had a blood stem cell transplant within 3 months before treatment starts, or still have transplant side effects rated grade 2 or higher that do not involve blood cells.
  • Have active graft-versus-host disease (GVHD), where donor cells attack your body, that needs medicine to lower immune system activity.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

GA