OncoMatch/Clinical Trials/NCT05233618
Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)
Is NCT05233618 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Tagraxofusp for myelofibrosis.
Treatment: Tagraxofusp — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myeloproliferative Neoplasm
Acute Myeloid Leukemia
Biomarker criteria
Required: IL3RA overexpression (CD123+)
is CD 123+
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: allogeneic stem cell transplant — first transplant, 60-120 days prior to study registration
Receipt of first allogeneic stem cell transplant (related, unrelated, haploidentical or cord blood) 60-120 days prior to study registration
Cannot have received: tagraxofusp (tagraxofusp)
Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product
Cannot have received: disease-related therapy, including radiation therapy or investigational agent
Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry
Lab requirements
Blood counts
ANC ≥0.5 × 10⁹/L; Platelets ≥ 80,000/mm³
Kidney function
Serum Creatinine ≤ 1.5 mg/dL
Liver function
Bilirubin ≤1.5 mg/dL; AST and ALT ≤2.5x ULN; Serum albumin ≥3.2 (albumin infusions not permitted)
Cardiac function
LVEF ≥ 50% by MUGA or 2-D ECHO; no clinically significant abnormalities on ECG
adequate baseline organ function, including cardiac, renal, and hepatic function within 28 days of start of therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Thomas Jefferson University · Philadelphia, Pennsylvania
- University of Virginia · Charlottesville, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05233618 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tagraxofusp, disease-related therapy, including radiation therapy or investigational agent disqualifies patients from enrollment.
Does this trial require IL3RA?
Yes, IL3RA overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify