NCT07511062Not 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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 25 Mar 2026
- Start date
- 31 Jan 2027
- Primary completion date
- 1 Aug 2029
- Lead sponsor
- Northside Hospital, Inc.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07511062
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 31 Jan 2027 to the primary completion date, 1 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- hematopoietic stem cell transplantation within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade 2+ related to the transplant
Other illness
- active uncontrolled infection
- history of HIV or active HBV or HBC infection
- currently active second malignancy
- history of acute or chronic pancreatitis, history of myositis
Lab values
- AST and/or ALT and/or direct bilirubin \>3x ULN
- cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias
Other
- KPS \<60
- calculated CrCl \<40mL/min
- known leukemia involvement of CNS
- active acute or chronic GVHD requiring immunosuppressive treatment
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northside Hospital, Inc. Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.