← Back to Search

Immunotoxin

Tagraxofusp for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Caspian Oliai, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
AML in first or second remission meeting specific criteria (CR, CRi, morphologic leukemia-free state)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial tests a recombinant protein and a drug to kill cancer cells in patients with acute myeloid leukemia.

Who is the study for?
This trial is for adults over 18 with acute myeloid leukemia in first or second remission, who have measurable residual disease and are not pregnant or breastfeeding. They must have a certain level of organ function and cannot be undergoing certain other treatments or have uncontrolled heart conditions.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Tagraxofusp, alone or with Azacitidine, to kill cancer cells in patients with acute myeloid leukemia that's in remission but still detectable at very low levels. The goal is to clear these cells before a stem cell transplant.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response, such as inflammation in various organs; symptoms from the toxin component like fever and weakness; and potential blood-related issues due to bone marrow suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My AML is in the first or second remission.
Select...
My cancer cells tested positive for CD123.
Select...
I am not pregnant, have tested negative recently, and am not breastfeeding.
Select...
I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity
Secondary outcome measures
MRD
MRD progression
Measurable residual disease (MRD)
+4 more
Other outcome measures
CD123 expression via immunohistochemical stain on leukemia blasts in the bone marrow specimen
T-cell (CD3) chimerism via short tandem repeat assay

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort II (azacitidine, tagraxofusp-erzs)Experimental Treatment2 Interventions
Patients receive azacitidine SC daily on days 1-5 and tagraxofusp-erzs IV QD over 15 minutes on days 8-12. Treatment repeats every 28-42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (tagraxofusp-erzs)Active Control1 Intervention
Patients receive tagraxofusp-erzs IV QD over 15 minutes on days 1-5. Treatment repeats every 28-42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Tagraxofusp-erzs
2020
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,076 Total Patients Enrolled
Stemline Therapeutics, Inc.OTHER
18 Previous Clinical Trials
1,885 Total Patients Enrolled
Caspian Oliai, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
3 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Tagraxofusp-erzs (Immunotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05720988 — Phase 1
Acute Myeloid Leukemia Clinical Trial 2023: Tagraxofusp-erzs Highlights & Side Effects. Trial Name: NCT05720988 — Phase 1
Tagraxofusp-erzs (Immunotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05720988 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Cohort I (tagraxofusp-erzs), Cohort II (azacitidine, tagraxofusp-erzs)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree does Cohort II (azacitidine, tagraxofusp-erzs) endanger individuals?

"The safety rating of Cohort II (azacitidine, tagraxofusp-erzs) was pegged at a 1 due to its limited Phase 1 trial data backing up the efficacy and security of this medication."

Answered by AI

Are there any vacancies in this clinical trial still available?

"According to clinicaltrials.gov, this medical study is no longer looking for volunteers, as the trial was last updated on January 31st 2023 after being posted on March 3rd of the same year. However, there are still 1564 other trials that are open and recruiting participants at this time."

Answered by AI
~0 spots leftby Aug 2025