Actively Recruiting
Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML
Led by Stanford University · Updated on 2026-04-14
20
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.
CONDITIONS
Official Title
Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory acute myeloid leukemia (AML) per WHO 2022 criteria
- Expression of CD123 confirmed by flow cytometry or immunohistochemistry
- Previously treated with venetoclax plus a hypomethylating agent (azacitidine or decitabine) unless treated with IDH or FLT3 inhibitors
- Age 18 years or older
- ECOG performance status of 2 or less
- Albumin level of 3.2 g/dL or higher without albumin supplementation
- Left ventricular ejection fraction of 50% or higher
- No significant abnormalities on 12-lead ECG including no complete left bundle branch block, third-degree or second-degree heart block, PR interval over 250ms, or QTcF over 450ms on three measurements
- Willingness to comply with all study procedures and availability for the study duration
- Females of reproductive potential must commit to abstinence or use highly effective contraception during treatment and for 30 days after last dose
- Males of reproductive potential must agree to use condoms
- Adequate liver function defined as total bilirubin 1.5 times ULN or less (except Gilbert's disease or leukemic involvement) and AST or ALT 3 times ULN or less
- Adequate kidney function with creatinine clearance over 30 mL/min
- Negative pregnancy test for women of childbearing potential
- Ability to understand and provide written informed consent
You will not qualify if you...
- Prior therapy other than venetoclax plus a hypomethylating agent, or this followed by IDH or FLT3 inhibitors
- Receiving systemic anti-cancer therapy less than 14 days before starting study drug (hydroxyurea allowed in first cycle only)
- Significant cardiac disease including NYHA Class 3 or 4 heart failure, uncontrolled angina, recent heart attack or stroke within 6 months, uncontrolled hypertension, or uncontrolled arrhythmias
- Any uncontrolled bacterial, fungal, viral, or other infection
- Known HIV positive or active hepatitis B or C infection
- Persistent grade 2 or higher toxicities from prior treatments not controlled by supportive care (except alopecia, nausea, fatigue)
- Active malignancy or cancer history that may affect study outcome, except certain skin and prostate cancers
- Uncontrolled significant lung disease
- Known or suspected active central nervous system disease
- Receiving immunosuppressive therapy except low-dose prednisone (10 mg/day or less)
- Previous allogenic stem cell transplant
- Uncontrolled illness that may limit study compliance
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
W
Woo In (Yustina) Cho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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