💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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 Criteria:
* 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
💊
What it tests
- total marrow/lymphoid irradiation
Università degli Studi di Perugia
Perugia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.