Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MF and CMML (HSCT 002)

  • End date
    Oct 1, 2026
  • participants needed
  • sponsor
    Karen Ballen, MD
Updated on 4 October 2022
chronic myelomonocytic leukemia


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.


Relapsed disease is the primary cause of treatment failure after hematopoietic cell transplant (HCT). In this study, patients are given increasing levels of tagraxofusp (Tag) to evaluate the safety of each dose. Participants will start treatment with Tag starting between 60 and 120 days following HCT. Tag will be given by IV over about 15 minutes on days 1 through 3 of cycles 1-4 of treatment (28 day cycles) and then on days 1 and 2 of subsequent cycles, for up to 9 cycles or until disease progression or if you have a bad side effect. In the first cycle, Tag will be given while participants are inpatient. In all other cycles, Tag will be given outpatient and participants will be observed for 4 hours following each infusion. After about 4 cycles of treatment and again about 1 year after HCT, participants will have a bone marrow biopsy and also take a questionnaire about their quality of life. During the study, participants will have their blood checked regularly to monitor for side effects.

Condition Myelofibrosis, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia
Treatment tagraxofusp
Clinical Study IdentifierNCT05233618
SponsorKaren Ballen, MD
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease
Known active or suspected disease involvement of the central nervous system (CNS)
Receiving > 10 mg prednisone daily for GVHD
Overall Grade 2 or greater acute GVHD (per Magic criteria) at time of registration
Pregnant or breast feeding
Requirement of supplemental oxygen
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, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study
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
Known positive status for human immunodeficiency virus or active or chronic Hepatitis B or Hepatitis C
Receiving treatment for known or suspected fungal infection (prophylaxis is acceptable)
Known positive SARS-COV-2 test within 3 weeks of study entry
Pedal edema >= grade 2

Exclusion Criteria

Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry
Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product
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