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

ConditionsAcute Myeloid Leukaemia (AML)Acute Lymphoblastic Leukemia ALL High Risk Leukaemia Leukaemia Relapse

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity Of Perugia

About this trial

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

Qualifiers

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.

Disqualifiers

AML patients

AML in CR MRD-

AML with > 5% peripheral blasts or bone marrow infiltration ≥ 30%

Age < 18 years or > 65 years

Trial design

Treatments tested in this trial

total marrow/lymphoid irradiation

Treatment groups

51 Participants

are divided into 1 treatment group

Sponsors and collaborators

University Of Perugia

Lead sponsor

Source ClinicalTrials.gov