Vaccination of haemopoietic stem cell transplant recipients: guidelines of the 2017 European Conference on Infections in Leukaemia (ECIL 7).
Catherine Cordonnier, Sigrun Einarsdottir, Simone Cesaro...
https://pubmed.ncbi.nlm.nih.gov/30744963Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06845592
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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a specialized treatment for patients with high-risk acute leukemia, including Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL). This study focuses on combining a targeted high-dose radiation regimen with an innovative immunotherapy using donor regulatory and conventional T cells. The goal is to improve outcomes for those undergoing hematopoietic stem cell transplantation (HSCT). All participants will receive a conditioning treatment using a total marrow/lymphoid irradiation (TMLI) at a dose of 20 Gy. This is followed by the infusion of donor stem cells along with Treg/Tcon adoptive immunotherapy. The donor cells come from family or unrelated donors who are either fully or partially matched to the patient’s immune system. This approach aims to enhance the effectiveness of the transplant. During the study, participants will be closely monitored for disease status, graft success, and complications such as graft-versus-host disease (GvHD). Key assessments include checking the number of patients free from disease two years after transplantation and monitoring engraftment at 45 days. Safety and long-term outcomes will be evaluated over a two-year period. The total involvement duration varies depending on individual progress and response.
CONDITIONS
Brief 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
Age: 18Years - 65Years
All Genders
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 minimal residual disease (MRD) or active disease with bone marrow infiltration 5-30% at transplant
- Availability of a suitable hematopoietic stem cell donor (family or unrelated, HLA-matched or haploidentical) able to undergo G-CSF treatment and leukaphereses
- Age between 18 and 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) of 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 bone marrow infiltration 5-30% or at least second complete hematologic remission at transplant
- Availability of suitable hematopoietic stem cell donor as above
- Age between 18 and 65 years
- ECOG performance status of 2 or less
- HCT-CI of 4 or less
- No relevant psychiatric diseases
- Signed informed consent
You will not qualify if you...
- AML in complete remission with negative MRD
- AML with more than 5% peripheral blasts or bone marrow infiltration 30% or higher
- Age under 18 or over 65 years
- ECOG performance status greater than 2
- Unacceptable lung, liver, kidney, or heart function
- Relevant psychiatric diseases per clinical judgment
- Pregnancy
- No signed informed consent
- ALL with more than 5% peripheral blasts or bone marrow infiltration 30% or higher
- Philadelphia positive ALL
- Age under 18 or over 65 years
- ECOG performance status greater than 2
- Unacceptable lung, liver, kidney, or heart function
- Relevant psychiatric diseases per clinical judgment
- Pregnancy
- No signed informed consent
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years
Participants receive a 20 Gy total marrow/lymphoid irradiation (TMLI) based conditioning regimen followed by infusion of donor graft and adoptive immunotherapy with regulatory and conventional T cells.
Multiple visits during conditioning, infusion, and follow-up for up to 2 years
Trial Site Locations
Total: 1 location
1
Università degli Studi di Perugia
Perugia, PG, Italy, 06100
Actively Recruiting
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Research Team
A
Antonio Pierini
L
Loredana Ruggeri
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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Published Research Related To This Trial
Post-transplant cyclophosphamide use in matched HLA donors: a review of literature and future application.
Riad El Fakih, Shahrukh K Hashmi, Stephen O Ciurea...
https://pubmed.ncbi.nlm.nih.gov/31089284Review of conditioning regimens for haplo-identical donor transplants using post-transplant cyclophosphamide in recipients of G-CSF mobilised peripheral stem cell.
Sushrut Patil, Victoria Potter, Mohamad Mohty
https://pubmed.ncbi.nlm.nih.gov/32717620Survival after T cell-depleted haploidentical stem cell transplantation is improved using the mother as donor.
Martin Stern, Loredana Ruggeri, Antonella Mancusi...
https://pubmed.ncbi.nlm.nih.gov/18492955Effectiveness of donor natural killer cell alloreactivity in mismatched hematopoietic transplants.
Loredana Ruggeri, Marusca Capanni, Elena Urbani...
https://pubmed.ncbi.nlm.nih.gov/11896281The European Society for Blood and Marrow Transplantation (EBMT) Consensus Guidelines for the Detection and Treatment of Donor-specific Anti-HLA Antibodies (DSA) in Haploidentical Hematopoietic Cell Transplantation.
Stefan O Ciurea, Kai Cao, Marcelo Fernandez-Vina...
https://pubmed.ncbi.nlm.nih.gov/29335625Optimization of PCR-based minimal residual disease diagnostics for childhood acute lymphoblastic leukemia in a multi-center setting.
V H J van der Velden, E R Panzer-Grümayer, G Cazzaniga...
https://pubmed.ncbi.nlm.nih.gov/17287857Analysis of minimal residual disease by Ig/TCR gene rearrangements: guidelines for interpretation of real-time quantitative PCR data.
V H J van der Velden, G Cazzaniga, A Schrauder...
https://pubmed.ncbi.nlm.nih.gov/17287850A multiplex reverse transcriptase-polymerase chain reaction strategy for the diagnostic molecular screening of chimeric genes: a clinical evaluation on 170 patients with acute lymphoblastic leukemia.
Loredana Elia, Marco Mancini, Luisa Moleti...
https://pubmed.ncbi.nlm.nih.gov/12651265MRD in ALL: Optimization and Innovations.
Eric Pierce, Benjamin Mautner, Joseph Mort...
https://pubmed.ncbi.nlm.nih.gov/35616771