Radiation and immune cells to improve stem cell transplant for aggressive leukemia

Plain-English translation of NCT06845592 on ClinicalTrials.gov ↗ · Source last updated March 2025 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing whether adding specially designed immune cells (called Treg/Tcon adoptive immunotherapy) to a stem cell transplant—along with a targeted radiation treatment—can help people with aggressive acute leukemia have better outcomes. In a stem cell transplant, radiation is used to prepare the body, then healthy blood-forming stem cells from a donor are given to rebuild the immune system. The new treatment adds immune cells from the same donor to help the transplant work more effectively and may reduce complications.

Acute leukemia is a serious blood cancer that often requires a stem cell transplant to have the best chance of survival. However, transplants don't always work as well as doctors hope, and they can cause serious side effects. This trial exists to see if adding this special immune cell therapy can make transplants safer and more successful for people with high-risk disease.

Do you qualify?

You likely qualify if…

you have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that is high-risk or not responding well to treatment
you are between 18 and 65 years old
you have a compatible stem cell donor available (family member or matched unrelated donor)
your heart, lungs, liver, and kidneys are working well enough to tolerate a transplant
you are mentally able to understand the study and give informed consent

You likely don't qualify if…

you have leukemia that is in complete remission with no detectable cancer cells remaining
you have more than 5% cancer cells in your blood or 30% or more in your bone marrow
you are pregnant or unable to avoid pregnancy during the trial
your heart, lungs, liver, or kidneys are not working well enough to safely tolerate this treatment
you have a serious untreated psychiatric condition that would prevent you from safely participating

What participation looks like

You would receive high-dose radiation to prepare your body for the transplant, then receive stem cells from your matched donor followed by a single infusion of specially prepared immune cells from that same donor. The study takes place at a single center in Italy and involves hospitalization for the transplant procedure and recovery, with follow-up visits to monitor your response to treatment and watch for any side effects. Your donor would undergo a brief outpatient procedure to collect the stem cells and immune cells needed for your transplant.

AI-generated summary from trial data · Jun 30, 2026 · Not medical advice

Trial locations(1 site)

Italy

Università degli Studi di Perugia, Perugia, PG