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Anti-metabolites

Tagraxofusp + Venetoclax + Azacitidine for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Research Sponsored by Stemline Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights

Summary

"This trial will be split into two parts. The first part will test different doses of tagraxofusp with venetoclax and azacitidine to find the best dose for the second part

Who is the study for?
This trial is for adults with a type of blood cancer called CD123+ Acute Myeloid Leukemia (AML) who haven't been treated yet and can't handle strong chemotherapy. The specific criteria to join or reasons you can't participate aren’t listed here.
What is being tested?
The study tests different doses of Tagraxofusp combined with Venetoclax and Azacitidine in two parts. Part 1 finds the right dose, which is then used in Part 2 to see how well it works for treating AML without intense chemo.
What are the potential side effects?
Possible side effects from Tagraxofusp, Venetoclax, and Azacitidine may include nausea, fatigue, bleeding problems, infections due to low blood cell counts, liver issues, and allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 2: Number of Participants Achieving a Best Overall Response (BOR) of Complete Remission (CR)
Secondary outcome measures
Parts 1 and 2: CR with Minimal Residual Disease (MRD) Negative
Parts 1 and 2: Duration of Response
Parts 1 and 2: Event-free Survival (EFS)
+10 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2 - Tagraxofusp (Selected Dose)Experimental Treatment3 Interventions
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
Group II: Part 1 - Tagraxofusp (Dose 2)Experimental Treatment3 Interventions
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
Group III: Part 1 - Tagraxofusp (Dose 1)Experimental Treatment3 Interventions
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440

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Who is running the clinical trial?

Stemline Therapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
2,125 Total Patients Enrolled
~51 spots leftby Feb 2028
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