Irradiation-based Myeloablative Conditioning Followed by Treg/Tcon Immunotherapy in HSCT

  • End date
    Feb 28, 2023
  • participants needed
  • sponsor
    University Of Perugia
Updated on 23 January 2021
chronic myeloid leukemia
stem cell transplantation
graft versus host disease
myeloid leukemia
lymphoid leukemia
hematologic malignancy
chronic lymphocytic leukemia
multiple myeloma
hodgkin's disease
acute leukemia
cell transplantation
myeloablative conditioning
myeloproliferative syndromes


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.


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).

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
Treatment High dose irradiation conditioning + Treg/Tcon
Clinical Study IdentifierNCT03977103
SponsorUniversity Of Perugia
Last Modified on23 January 2021


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Inclusion Criteria

Is your age less than or equal to 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Bone marrow disorder or Non-Hodgkin's Lymphoma or Lymphoproliferative Disorder or childhood ALL or Lymphoma or Acute Myelogenous Leukemia (AML) or Lym...?
Do you have any of these conditions: myeloproliferative neoplasm or Hematologic Malignancy or multiple myeloma (mm) or Hematologic Cancer or lymphomas or Acute Myelogenous Leukemia (AML) ...?
AML and ALL in complete remission and with high-risk of relapse
AML and ALL primarily chemoresistant or relapsed
Chronic Myeloid Leukemia in accelerated or blastic phase
Patients affected by
Multiple myeloma
Non Hodgkin lymphoma
Hodgkin lymphoma
Chronic myeloproliferative syndrome
Chronic Lymphoid Leukemia
Other Hematological malignancy at high-risk of relapse or detectable disease and where a HSCT is indicated
Age <75 years
Acceptable lung, liver, kidney, and heart function and absence of relevant psichiatric diseases
Signature of the informed consent

Exclusion Criteria

Age >75 years
ECOG > 2
Not acceptable lung, liver, kidney, and heart function and presence of relevant psichiatric diseases
No signature of the informed consent
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