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Tagraxofusp for Leukemia Maintenance Post-Transplant

Phase 1
Recruiting
Led By Karen Ballen
Research Sponsored by Karen Ballen, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has adequate baseline organ function including cardiac, renal, and hepatic function within 28 days of start of therapy: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG), Serum Creatinine ≤ 1.5 mg/dL, Bilirubin ≤1.5 mg/dL, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN), Absolute neutrophil count (ANC) ≥0.5 × 10⁹/L, Platelets ≥ 80,000/mm^3, Serum albumin ≥3.2 (note that albumin infusions are not permitted in order to enable eligibility)
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
Must not have
Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed through 2 years after date of hct
Awards & highlights

Summary

This trial is testing the use of tagraxofusp to prevent relapse in patients with leukemia who have undergone allogeneic stem cell transplant.

Who is the study for?
Adults aged 18-75 with CD123+ myelofibrosis, chronic myelomonocytic leukemia, or acute myeloid leukemia who've had a stem cell transplant within the last 60-120 days. They should be in remission post-transplant and have good organ function. Participants must agree to use contraception and adhere to lifestyle guidelines.
What is being tested?
The trial is testing Tagraxofusp as a maintenance therapy after allogeneic stem cell transplant for patients with certain blood cancers. It aims to prevent cancer relapse over up to nine treatment cycles, including bone marrow biopsies after cycle four and around one year post-transplant.
What are the potential side effects?
Specific side effects of Tagraxofusp are not listed but may include reactions at the infusion site, potential liver issues (as indicated by eligibility criteria on bilirubin levels), fatigue, immune system impacts (based on neutrophil count requirements), and other common drug-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart problems like uncontrolled heart failure or recent heart attack.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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My cancer has spread to or is suspected to be in my brain or spinal cord.
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I have moderate to severe swelling in my feet.
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I am currently experiencing a moderate to severe reaction from a transplant.
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I have never been treated with tagraxofusp and am not allergic to it.
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I need extra oxygen.
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I have HIV, Hepatitis B, or Hepatitis C.
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I am taking more than 10 mg of prednisone daily for graft-versus-host disease.
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I am currently being treated for a fungal infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed through 2 years after date of hct
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed through 2 years after date of hct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicities
Incidence and severity of grade ≥ 3 adverse events
Percent of planned tagraxofusp dose received
Secondary study objectives
Frequency and severity of acute GVHD grades II-IV and chronic GVHD
Time from HCT to relapse and death or last contact.

Side effects data

From 2020 Phase 1 & 2 trial • 138 Patients • NCT02113982
80%
Hypoalbuminaemia
60%
Pyrexia
60%
Oedema peripheral
50%
Fatigue
50%
Alanine aminotransferase increased
50%
Aspartate aminotransferase increased
50%
Thrombocytopenia
50%
Nausea
50%
Chills
40%
Neutropenia
40%
Hypotension
30%
Dyspnoea
30%
Hyperglycaemia
30%
Back pain
30%
Blood creatinine increased
30%
Capillary leak syndrome
30%
Hypertension
20%
Blood alkaline phosphatase increased
20%
Pruritus
20%
Activated partial thromboplastin time prolonged
20%
Anaemia
20%
Lymphocytosis
20%
Decreased appetite
20%
Hypomagnesaemia
20%
Abdominal pain
20%
Urinary tract infection
20%
Hyperuricaemia
20%
Hypokalaemia
20%
Haematuria
20%
Cough
20%
Lymphopenia
20%
Febrile neutropenia
20%
Vomiting
20%
Hypocalcaemia
20%
Hypophosphataemia
20%
Tumour lysis syndrome
20%
Mental status changes
20%
Pneumonia
10%
Stomatitis
10%
Anxiety
10%
Dyspnoea exertional
10%
Eye pain
10%
Abdominal pain upper
10%
Pain in extremity
10%
Proteinuria
10%
Epistaxis
10%
Nasal congestion
10%
Dry skin
10%
Leukopenia
10%
Hyperbilirubinaemia
10%
Infusion related reaction
10%
Blood fibrinogen decreased
10%
Musculoskeletal chest pain
10%
Insomnia
10%
Non Cardiac Chest Pain
10%
Metabolic Encephalopathy
10%
Headache
10%
Hypoxia
10%
Constipation
10%
Blood lactate dehydrogenase increased
10%
Bone pain
10%
Musculoskeletal pain
10%
Acute kidney injury
10%
Rash
10%
Deep vein thrombosis
10%
Blood creatine phosphokinase increased
10%
Escherichia Sepsis
10%
Asthenia
10%
Hypermagnesaemia
10%
Leukocytosis
10%
Diarrhoea
10%
International normalised ratio increased
10%
Transaminases increased
10%
Weight increased
10%
Hypernatraemia
10%
Hyponatraemia
10%
Neuropathy peripheral
10%
Aspartate Aminotransferase Increased
10%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
Stage 2 - AML Indication: 16 µg/kg/Day Dosage

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tagraxofusp (escalating doses)Experimental Treatment1 Intervention
IV tagraxofusp on days 1-3 of cycles 1-4 and days 1-2 of additional cycles for up to 9 cycles (some participants could receive more if considered in their best interest)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tagraxofusp
2014
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Karen Ballen, MDLead Sponsor
Karen BallenPrincipal InvestigatorUVA

Media Library

Tagraxofusp Clinical Trial Eligibility Overview. Trial Name: NCT05233618 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Tagraxofusp (escalating doses)
Acute Myeloid Leukemia Clinical Trial 2023: Tagraxofusp Highlights & Side Effects. Trial Name: NCT05233618 — Phase 1
Tagraxofusp 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233618 — Phase 1
~14 spots leftby Sep 2025
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