RecruitingPhase 1Phase 2NCT06561152

Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML

Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)


Sponsor

Stanford University

Enrollment

20 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of tagraxofusp with low-intensity chemotherapy for adults with acute myeloid leukemia (AML) that has returned or stopped responding to the standard first-line treatment of venetoclax plus a hypomethylating agent. **You may be eligible if...** - You are 18 or older with AML that has relapsed or is no longer responding to treatment - Your AML cells express a protein called CD123 - Your initial treatment was venetoclax combined with azacitidine or decitabine (with or without a subsequent IDH or FLT3 inhibitor) - Your heart function (ejection fraction) is at least 50% - Your liver and kidney function are adequate **You may NOT be eligible if...** - You have received treatments other than those specified above - You have significant heart disease (such as heart failure or a recent heart attack) - You have HIV or active hepatitis B or C - You are currently receiving immunosuppressive therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTagraxofusp

Tagraxofusp is administered by intravenous infusion (IV) over 15 minutes for 3 consecutive days of a 28-day cycle. (days 4-6)

DRUGCladribine (CLAD)

Cladribine 5mg/m2 IV once daily on days 1-3 (DL1) Cladribine 5mg/m2 IV once daily on days 1-4 (DL2) Cladribine 5mg/m2 IV once daily on days 1-5 (DL3)

DRUGCytarabine

Cytarabine 20mg/m2 IV daily days 1-5 (DL1) Cytarabine 20mg/m2 IV daily days 1-7(DL2) cytarabine 20mg/m2 IV daily days 1-10 (DL3)


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06561152


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