Irradiation-based Myeloablative Conditioning Followed by Treg/Tcon Immunotherapy in HSCT
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- STATUS
- Recruiting
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- End date
- Feb 28, 2023
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- participants needed
- 80
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- sponsor
- University Of Perugia
Summary
To evaluate if hyper-fractionated TBI or TMLI followed by Treg/Tcon adoptive immunotherapy improve cGvHD/disease free survival after allogeneic HSCT in patients affected by high-risk acute leukemias or other hematologic malignancy where HSCT is indicated.
Description
Improving cGvHD/disease free survival in patients with high-risk acute leukemias or other hematologic malignancy where HSCT is indicated with the use of a regulatory T cell based protocol. Hyper-fractionated Total Body Irradiation or Total Marrow and Lymphoid Irradiation based conditioning will be followed by the infusion of T regulatory and T conventional cell adoptive immunotherapy and a purified CD34+ hematopoietic stem cell graft. Incidence of Non Relapse Mortality, Relapse, acute Graft versus Host Disease, chronic Graft versus Host Disease, as well as probability of cGvHD/disease free survival will be assessed in patient subpopulations separated according to HLA-matching with the donor (HLA-matched HSCT and HLA-haploidentical HSCT) and type of disease (acute myeloid leukemia, acute lymphoid leukemia, lymphoma, multiple myeloma, myeloproliferative disease, and other).
Details
| Condition | Bone marrow disorder, childhood ALL, Hematologic Malignancy, Multiple Myeloma, Lymphoma, Acute myeloid leukemia, Lymphoproliferative Disorder, Lymphoma, MYELOPROLIFERATIVE DISORDER, Non-Hodgkin's Lymphoma, Acute Myelogenous Leukemia (AML), Myeloproliferative Neoplasms, Lymphocytic Leukemia, Acute, Blood Cancer, Hematologic Cancer, Hematologic Neoplasms, Lymphoproliferative disorders, Other Hematologic Malignant Neoplasms, leukemia, acute lymphoblastic, myeloproliferative neoplasm, myeloproliferative disorders, lymphomas, multiple myeloma (mm), acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia |
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| Treatment | High dose irradiation conditioning + Treg/Tcon |
| Clinical Study Identifier | NCT03977103 |
| Sponsor | University Of Perugia |
| Last Modified on | 23 January 2021 |
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