Actively Recruiting
Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)
Led by Karen Ballen, MD · Updated on 2025-05-28
44
Participants Needed
2
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, tagraxofusp (Tag) is given to patients with CD 123+ myelofibrosis (MF), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) after allogeneic stem cell transplant (HCT) to help prevent relapse. Patients will receive up to about 9 cycles of treatment with Tag and have a bone marrow biopsy after cycle 4 and about 1 year after HCT.
CONDITIONS
Official Title
Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate heart, kidney, and liver function within 28 days before starting therapy
- Left ventricular ejection fraction (LVEF) of 50% or higher with no significant ECG abnormalities
- Serum creatinine 1.5 mg/dL or less
- Bilirubin 1.5 mg/dL or less
- AST and ALT no more than 2.5 times the upper limit of normal
- Absolute neutrophil count at least 0.5 x 10^9/L
- Platelet count at least 80,000/mm3
- Serum albumin 3.2 or higher without albumin infusions
- Diagnosis meeting 2016 WHO criteria for MF, CMML, AML, or MDS with specific disease and risk features as detailed in the study
- First allogeneic stem cell transplant 60 to 120 days before study registration
- In morphologic remission confirmed by bone marrow biopsy within 30 days before treatment
- Signed informed consent
- Willingness to comply with study procedures and availability for study duration
- Use of adequate contraception for reproductive potential during study and specified time before and after
- Agreement to adhere to lifestyle considerations throughout the study
You will not qualify if you...
- Treatment with disease-related therapy, radiation, or investigational agents within 14 days before study entry
- Previous treatment with tagraxofusp or known allergy to its components
- Active cancer or history of cancer that may interfere with study results, except specified low-risk cancers
- Known active or suspected central nervous system disease involvement
- Taking more than 10 mg prednisone daily for graft-versus-host disease (GVHD)
- Grade 2 or higher acute GVHD at registration
- Pregnant or breastfeeding
- Need for supplemental oxygen
- Significant heart disease such as uncontrolled heart failure, angina, recent heart attack or stroke, uncontrolled hypertension, or serious arrhythmias
- Uncontrolled lung disease putting patient at risk
- Uncontrolled infections or illnesses that limit study compliance
- Positive HIV or active/chronic Hepatitis B or C infection
- Receiving treatment for fungal infection (except prophylaxis)
- Positive COVID-19 test within 3 weeks before study entry unless resolved and non-infectious
- Pedal edema grade 2 or higher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
2
University of Virginia
Charlottesville, Virginia, United States, 22901
Actively Recruiting
Research Team
S
Samantha Brooks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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