OncoMatch/Clinical Trials/NCT06498973
Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant
Is NCT06498973 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Tagraxofusp-erzs and Azacitidine for acute myeloid leukemia.
Treatment: Azacitidine · Tagraxofusp-erzs — This phase Ib trial tests the safety, side effects, best dose and effectiveness of tagraxofusp in combination with azacitidine as maintenance therapy in treating patients with CD123 positive acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after a donor (allogeneic) hematopoietic cell transplant. An allogeneic hematopoietic cell transplant (HCT) is a type of transplant where the cancer patient receives cells from another person. Maintenance therapy is given after the transplant to prevent the cancer from coming back. Tagraxofusp is a drug that targets cells that have CD123 on their surface in order to kill the cancer cells to help prevent the cancer from coming back. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Giving tagraxofusp in combination with azacitidine may be safe, tolerable and/or effective maintenance therapy in patients with CD123 positive AML and MDS after an allogeneic HCT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: IL3RA overexpression (CD123 positive (>20% of abnormal population by flow cytometry))
Positive for CD123 by flow cytometry of either peripheral blood or bone marrow aspirates at the time of diagnosis at any time-point prior to HCT. ... If more than 20% of the abnormal population is positive relative to this control, it will be classified as positive.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: allogeneic hematopoietic cell transplant — first or second HCT-eligible OR post-HCT
First or second allogeneic HCT-eligible patients with AML or MDS ... OR patients who underwent HCT for AML or MDS
Cannot have received: anti-CD123 therapy
Exception: allowed if no progression is documented on therapy and no anti-CD123 therapy after allogeneic HCT
Prior treatment with CD123-therapy is allowed if no progression is documented on therapy; No treatment with anti-CD123 therapy after allogeneic HCT
Cannot have received: investigational agent
Exception: within 14 days of study entry
The patient has not received treatment with another investigational agent within 14 days of study entry
Lab requirements
Blood counts
ANC ≥ 1.5 (within 7 days of day 1 of the cycle 1); Hemoglobin (HbG) ≥ 7; Platelet count ≥ 20K (transfusion allowed to achieve counts); Full engraftment: ANC ≥ 500 for 3 days and platelets > 20,000 without transfusion for 7 days
Kidney function
Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 2 x ULN (unless has Gilbert's disease); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Serum albumin > 3.2 (albumin infusions not permitted for eligibility)
Total bilirubin ≤ 2 x ULN (unless has Gilbert's disease); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Serum albumin > 3.2; Creatinine clearance of ≥ 30 mL/min; ANC ≥ 1.5; Hemoglobin (HbG) ≥ 7; Platelet count ≥ 20K; Full engraftment: ANC ≥ 500 for 3 days and platelets > 20,000 without transfusion for 7 days
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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