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

March 31, 2026 updated by: Northside Hospital, Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axatilimab+Decitabine+Venetoclax
Drug: Decitabine
20mg/m2/d x5 days (induction & consolidation)
Drug: Venetoclax
400mg/d x14 days (induction); 400mg/d x7 days (consolidation)
Drug: Axatilimab
Dose escalation, given on Days 1 and 15 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northside Hospital, Inc.

Collaborators

Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSH 1436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Endpoints are looking at overall responses and efficacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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