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

ConditionsAcute Myeloid LeukemiaTP53 Gene Mutation
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthside Hospital, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

KPS <60

active uncontrolled infection

history of HIV or active HBV or HBC infection

currently active second malignancy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Axatilimab+Decitabine+VenetoclaxExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Phase 2 Dose Level determination

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.

Time frame
1 year
2

Estimation of MRD-negative complete remission

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

Time frame
2 months

Secondary outcomes

1

Estimation of Response Rates, Overall Survival

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

Time frame
1 year
2

Evaluation of Safety of the Regimen

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

Time frame
1 year
3

Estimation of Progression Free Survival

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

Time frame
1 year
4

Estimation of Overall Survival

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northside Hospital, Inc.

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: