High-dose irradiation followed by immunotherapy for high-risk leukemia patients
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
This study is testing a new treatment that combines high-dose radiation with special immune cells to see if it helps patients with high-risk leukemia do better after a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Of Perugia Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Perugia, PG) |
| Trial ID | NCT06845592 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a treatment approach that combines high-dose total marrow and lymphoid irradiation with adoptive immunotherapy using donor Treg and conventional T cells for patients with high-risk acute leukemia. It focuses on patients who are undergoing allogeneic hematopoietic stem cell transplantation and have specific genetic risks or active disease. The study aims to enhance the potency of the transplantation process to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with acute myeloid leukemia or acute lymphoblastic leukemia who are eligible for allogeneic hematopoietic cell transplantation.
Not a fit: Patients with low-risk leukemia or those who do not meet the eligibility criteria for transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and outcomes for patients with high-risk acute leukemia.
How similar studies have performed: While this approach is innovative, similar studies involving high-dose irradiation and immunotherapy have shown promise in improving outcomes for leukemia patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Perugia, PG
- Università degli Studi di Perugia — Perugia, Pg, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio Pierini
- Email: antonio.pierini@unipg.it
- Phone: +393355477611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.