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

Launched by UNIVERSITY OF PERUGIA · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with high-risk acute leukemia, specifically those with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). The trial aims to see if using a combination of targeted high-dose radiation therapy followed by a special kind of immune therapy (using donor T cells) can enhance the effectiveness of stem cell transplantation. This treatment is designed for patients who have a high chance of leukemia returning after standard treatments.

To participate in this trial, patients need to be between 18 and 65 years old and have a diagnosis of either AML or ALL with certain challenging characteristics, such as having an active disease or specific genetic risks. Participants will need a suitable stem cell donor, which can be a family member or someone unrelated. Throughout the trial, patients can expect close monitoring and support from the medical team as they undergo the treatment. It's important for potential participants to understand the eligibility requirements and discuss any questions with their healthcare provider to see if this trial is a good fit for them.

Gender

ALL

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