RecruitingPhase 2NCT05800210

Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases


Sponsor

University of Florida

Enrollment

20 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.


Eligibility

Min Age: 6 MonthsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of stem cell transplant for children, teens, and young adults with blood cancers. The transplant uses donor stem cells that have been carefully filtered to remove certain immune cells, which may reduce the risk of serious complications after transplant. **You may be eligible if:** - You are between 6 months and 39 years old - You have a blood cancer such as acute leukemia (ALL or AML), juvenile myelomonocytic leukemia, CML, high-risk myelodysplastic syndrome, or lymphoma (Hodgkin or Non-Hodgkin) - Your cancer is high-risk, in second remission or beyond, or did not respond well to initial treatment - A matching donor (related sibling, unrelated donor, or half-matched family member) is available - Your heart, lungs, kidneys, and liver are functioning well enough **You may NOT be eligible if:** - You have an active, uncontrolled infection - You had a stem cell transplant from a donor within the last 6 months - You have active graft-versus-host disease (a reaction where donor cells attack your body) - You are pregnant or breastfeeding - You are currently incarcerated 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

DEVICEMiltenyi CliniMACS Prodigy ® system

Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT05800210


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