Actively Recruiting
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
Led by University Of Perugia · Updated on 2025-03-04
51
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML with indication for allogeneic hematopoietic cell transplantation
- Diagnosis of adverse genetic risk leukemia or presence of measurable residual disease (MRD) or active disease with 5-30% bone marrow infiltration at transplant
- Availability of a suitable hematopoietic stem cell donor (family or unrelated HLA-matched or haploidentical) able to receive G-CSF and tolerate leukapheresis
- Age between 18 and 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score 4 or less
- No relevant psychiatric diseases
- Signed informed consent
- Diagnosis of ALL (T or B, Philadelphia negative, or mixed phenotype) with indication for allogeneic transplant
- Presence of MRD or active disease with 5-30% bone marrow infiltration or patient in second or higher complete hematologic remission at transplant
- Same donor and age criteria as AML patients
- Same ECOG, HCT-CI, psychiatric, and consent criteria as AML patients
You will not qualify if you...
- AML patients in complete remission MRD negative
- AML patients with more than 5% peripheral blasts or 30% or more bone marrow infiltration
- Patients younger than 18 or older than 65 years
- ECOG performance status greater than 2
- Unacceptable lung, liver, kidney, or heart function or relevant psychiatric diseases
- Pregnancy
- No signed informed consent
- ALL patients with more than 5% peripheral blasts or 30% or more bone marrow infiltration
- Philadelphia positive ALL
- Same age, ECOG, organ function, psychiatric, pregnancy, and consent exclusion criteria as AML patients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Università degli Studi di Perugia
Perugia, PG, Italy, 06100
Actively Recruiting
Research Team
A
Antonio Pierini
CONTACT
L
Loredana Ruggeri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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