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Anti-metabolites

Tagraxofusp + Chemotherapy for AML

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

Albumin ≥ 3.2 g/dL at time of screening (note that albumin supplementation is not permitted to enable eligibility)

Females of reproductive potential need to either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with highly effective contraception without interruption prior to starting treatment, during the study therapy, and for 30 days after last dose of study therapy

Must not have

The patient has persistent clinically significant toxicities Grade >/= 2 from previous therapies not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue).

Prior therapy apart from Venetoclax in combination with a hypomethylating agent, or Venetoclax in combination with a hypomethylating agent followed by monotherapy with IDH or FLT3 inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up 2 years

Awards & highlights

Summary

"This trial aims to test how well a combination of tagraxofusp, cladribine, and cytarabine works together."

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

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My albumin level is at least 3.2 g/dL without supplements.

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I am using or willing to use effective birth control during and after the study.

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My kidneys work well enough (creatinine clearance over 30 mL/min).

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My cancer cells show CD123 presence.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a woman who can have children and have a negative pregnancy test.

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My AML has come back or didn't respond to treatment according to WHO criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lasting side effects from past treatments that are moderate to severe, except for hair loss, nausea, or tiredness.

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I have been treated with Venetoclax and specific other drugs for my condition.

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I do not have serious heart conditions like severe heart failure, recent heart attacks, or uncontrolled high blood pressure.

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I do not have any untreated infections.

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I have HIV or active hepatitis B or C.

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I have had a stem cell transplant from a donor.

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I do not have any uncontrolled illnesses that would stop me from following the study rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up 2 years

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

Tagraxofusp

2014

Completed Phase 2

~140

Cytarabine

2016

Completed Phase 3

~3330

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stemline Therapeutics, Inc.OTHER

22 Previous Clinical Trials

6,383 Total Patients Enrolled

Stanford UniversityLead Sponsor

2,448 Previous Clinical Trials

17,492,374 Total Patients Enrolled

~13 spots leftby Oct 2026

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