RecruitingPhase 1NCT06498973

Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant

CD123 Antibody Toxin Congregate (CD123 ATC; Tagraxofusp) Combined With Azacitidine for Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for Patients With CD123-Positive Malignant

Sponsor

City of Hope Medical Center

Enrollment

43 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a maintenance therapy combining tagraxofusp (a targeted drug that attacks CD123, a protein found on certain cancer cells) and azacitidine (a chemotherapy drug) can prevent blood cancer from coming back in patients with AML (acute myeloid leukemia) or MDS (myelodysplastic syndrome) who have had a bone marrow transplant. **You may be eligible if...** - You are between 18 and 75 years old and have had your first or second bone marrow (allogeneic) transplant for AML or MDS with high-risk features - Your cancer cells are CD123 positive (a marker on the surface of cancer cells) - Your general health score (ECOG) is ≤ 2 and your organ function is adequate post-transplant **You may NOT be eligible if...** - Your cancer cells do not express the CD123 marker - You have active graft-versus-host disease (a complication of transplant) above a certain severity - You have serious organ dysfunction or active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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