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
University Of Perugia
51 participants
Feb 25, 2025
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
Inclusion Criteria18
- 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.
- Age ≥ 18 and ≤ 65 years
- ECOG ≤ 2
- HCT-CI ≤ 4
- Absence of relevant psychiatric diseases
- Signature of the informed consent
Exclusion Criteria16
- 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
- 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
Interventions
Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06845592