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 (May 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
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)
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
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