NCT06845592 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
| NCT ID | NCT06845592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Of Perugia |
| Condition | Acute Myeloid Leukaemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 51 participants in total. It began in 2025-02-25 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06845592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Myeloid Leukaemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06845592 currently recruiting?
Yes, NCT06845592 is actively recruiting participants. Contact the research team at antonio.pierini@unipg.it for enrollment information.
Where is the NCT06845592 trial being conducted?
This trial is being conducted at Perugia, Italy.
Who is sponsoring the NCT06845592 clinical trial?
NCT06845592 is sponsored by University Of Perugia. The trial plans to enroll 51 participants.