RecruitingPhase 1NCT05233618

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

Phase I Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelofibrosis and Chronic Myelomonocytic Leukemia


Sponsor

Karen Ballen, MD

Enrollment

44 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating a drug called tagraxofusp as a maintenance therapy (ongoing treatment to prevent relapse) after a stem cell transplant in patients with certain blood cancers — specifically AML (acute myeloid leukemia), MDS (myelodysplastic syndrome), myelofibrosis, or CMML — whose cancer cells carry a marker called CD123. **You may be eligible if...** - You are between 18 and 75 years old - You have AML, MDS, myelofibrosis, or CMML with CD123-positive cancer cells - You have recently undergone a stem cell (bone marrow) transplant - You have adequate organ function (heart, kidney, liver) - Your life expectancy is greater than 6 months **You may NOT be eligible if...** - Your cancer cells do not express the CD123 marker - You have serious organ dysfunction - You have active serious infections or graft-versus-host disease requiring high-dose steroids - 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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Interventions

DRUGTagraxofusp

inpatient on days 1-3 of cycles 1-4 and days 1-2 of additional cycles


Locations(2)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05233618


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