RecruitingNot ApplicableNCT06845592

Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia

SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia


Sponsor

University Of Perugia

Enrollment

51 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an advanced bone marrow transplant approach for patients with high-risk acute leukemia, combining targeted high-dose radiation (delivered precisely to the bone marrow) with specially prepared immune cells from a donor, in the hope of improving transplant success and reducing relapse. **You may be eligible if...** - You are between 18 and 65 years old with a diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) - Your leukemia is high-risk or has not fully responded to treatment (some residual disease is present) - You have a suitable bone marrow donor (family, unrelated matched, or half-matched) - You are otherwise healthy enough for a stem cell transplant **You may NOT be eligible if...** - You have significant other health problems that would make transplant too risky - You do not have a suitable donor - You have severe organ dysfunction 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

RADIATIONtotal marrow/lymphoid irradiation

Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation


Locations(1)

Università degli Studi di Perugia

Perugia, PG, Italy

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NCT06845592


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