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
NCT06845592 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2025-03-04
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.
Conditions
- Acute Myeloid Leukaemia (AML)
- Acute Lymphoblastic Leukemia ALL
- High Risk Leukaemia
- Leukaemia Relapse
Interventions
- RADIATION
-
total marrow/lymphoid irradiation
Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation
Sponsors & Collaborators
-
University Of Perugia
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-25
- Primary Completion
- 2029-01-31
- Completion
- 2031-01-31
Countries
- Italy
Study Locations
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