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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

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About this study

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.

Condition
Acute Myeloid Leukaemia (AML), Acute Lymphoblastic Leukemia ALL, High Risk Leukaemia, Leukaemia Relapse
Tested
total marrow/lymphoid irradiation
Sponsor
University Of Perugia

Who can join

Age
18 to 65 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 17

  • Minimum age: 18 years
  • Maximum age: 65 years
  • Study condition: Acute Myeloid Leukaemia (AML), Acute Lymphoblastic Leukemia ALL, High Risk Leukaemia, Leukaemia Relapse
  • AML patients
  • Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.
  • Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.
  • Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
  • Age ≥ 18 and ≤ 65 years
  • ECOG ≤ 2
  • HCT-CI ≤ 4 (51,52)
  • Absence of relevant psychiatric diseases
  • Signature of the informed consent
  • ALL patients
  • Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
  • Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
  • Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
  • HCT-CI ≤ 4

Exclusion 11

  • AML patients
  • AML in CR MRD-
  • AML with \> 5% peripheral blasts or bone marrow infiltration ≥ 30%
  • Age \< 18 years or \> 65 years
  • ECOG \> 2
  • Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
  • Pregnancy
  • No signature of the informed consent
  • ALL patients
  • ALL with \> 5% peripheral blasts or bone marrow infiltration ≥30%
  • Philadelphia positive ALL

Where

1 site, 1 recruiting

Università degli Studi di Perugia

Perugia, PG, Italy

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.