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Anti-metabolites

Dose Level -1 (DL-1) for Acute Myelogenous Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Documented diagnosis of relapsed or refractory acute myeloid leukemia (AML) according to World Health Organization (WHO) 2022 criteria
* Expression of CD123 by either flow cytometry or immunohistochemical staining with no minimum threshold for positivity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up 2 years
Awards & highlights

Summary

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

Who is the study for?
This trial is for individuals with a type of blood cancer called Acute Myeloid Leukemia (AML) that has come back or hasn't responded to treatment. Participants should have specific markers on their cancer cells (CD123-positive). Details about who can join are not fully provided, so interested persons should inquire further.
What is being tested?
The study is testing the effectiveness of combining a new drug, Tagraxofusp, with two chemotherapy drugs, Cladribine and Cytarabine. The goal is to see if this combination works better for treating AML than current treatments.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, nausea, fever, bleeding complications and increased risk of infections due to low blood cell counts. Specific side effects related to Tagraxofusp were not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recommended Phase 2 dose
Secondary study objectives
Complete response
Composite complete response (CR+CRi +CRh)
Duration of overall survival
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose level 3 (DL3)Experimental Treatment3 Interventions
DL3 will consist of cladribine 5mg/m2 IV once daily on days 1-5, cytarabine 20mg/m2 IV daily days 1-10, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
Group II: Dose level 2 (DL2)Experimental Treatment3 Interventions
DL2 will consist of cladribine 5mg/m2 IV once daily on days 1-4, cytarabine 20mg/m2 IV daily days 1-7, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
Group III: Dose level 1 (DL1)Experimental Treatment3 Interventions
DL1 will consist of cladribine 5mg/m2 IV once daily on days 1-3, cytarabine 20mg/m2 IV daily days 1-5, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
Group IV: Dose Level -1 (DL-1)Experimental Treatment3 Interventions
DL -1 will consist of cladribine 5mg/m2 IV once daily on days 1-2, cytarabine 20mg/m2 IV daily days 1-4, and tagraxofusp 12mcg/kg IV daily days 4-6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

Stemline Therapeutics, Inc.OTHER
21 Previous Clinical Trials
2,201 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,432 Previous Clinical Trials
17,465,311 Total Patients Enrolled
~13 spots leftby Oct 2026
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