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NCT05233618

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

Active, Not Recruiting
PHASE1Ages 18–75InterventionalTreatment
Karen Ballen, MD
~44 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Tagraxofusp

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of grade ≥ 3 adverse events
Measured over Through about 30 days following last infusion of tagraxofusp
+2 more outcomes measured

Conditions

Myelofibrosis
Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia

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Where it's being run

2 sites across 2 states
Pennsylvania1
Virginia1

Study leadership

  • Karen Ballen · PRINCIPAL_INVESTIGATOR · UVA

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) 5. Patient meets the 2016 WHO diagnostic criteria for MF, is CD 123+, and has an IPSS/DIPSS/DIPSS-plus intermediate-1 with anemia (Hb \< 10g/dl), splenomegaly (\> 12 cm), leukocytosis (WBC \> 25K) intermediate-2 or high-risk disease pre transplant.

What this trial measures

  • Incidence and severity of grade ≥ 3 adverse eventsThrough about 30 days following last infusion of tagraxofusp

    Severity is based upon CTCAE v5 criteria.

  • Dose limiting toxicitiesDuring cycles 1 and 2 (each cycle is 28 days) of study treatment for each participant

    Frequencies of certain, more severe, types of side effects from the study drug

  • Percent of planned tagraxofusp dose receivedThrough cycle 4 (each cycle is 28 days) of study treatment for each participant

    During cycles 1-4 only