Analyzing the immune response in relapsed Acute Myeloid Leukemia after stem cell transplant
Official title: Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways
Run by IRCCS San Raffaele · NCT05124288 · Data updated 2026-11-12
This study is trying to understand how the immune system reacts when Acute Myeloid Leukemia comes back after a stem cell transplant, to help create better treatment plans for patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Status | Recruiting |
| Started | July 18, 2022 |
| Main results expected | December 20, 2026 |
| Study ends | June 20, 2027 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT05124288 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients with Acute Myeloid Leukemia who have relapsed after allogeneic transplantation.
✕Probably not a fit
Patients currently participating in clinical protocols that exclude participation in other studies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to analyze the immunobiology of Acute Myeloid Leukemia (AML) relapses following allogeneic hematopoietic stem cell transplantation (HSCT). It involves both retrospective and prospective data collection from multiple centers, focusing on the identification of leukemic relapses characterized by Human Leukocyte Antigens loss and changes in gene expression. The goal is to develop personalized therapeutic pathways and guidelines to improve treatment strategies and patient outcomes. The study leverages collaboration among Italian transplant centers to standardize therapeutic management and promote innovative clinical studies.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with relapsed Acute Myeloid Leukemia.
How similar studies have gone: Other studies have shown promise in analyzing immunobiology in similar contexts, but this specific approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with Acute Myeloid Leukemia, who relapse after allogeneic transplantation from either family or unrelated donors, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood), who have signed the informed consent of the study; * For the coordinating center, all patients who have previously signed informed consent to the "Hematological Neoplasms Biobank" and for which samples, stored in the Biobank are available. * For the other centers, all patients who have previously signed an informed consent, aimed at the prior authorization for the storage of samples in the biobank of the aforementioned center, according to centers own practice, and for which samples, stored in a Biobank, are available. Exclusion Criteria: * Participation in clinical protocols that expressly exclude the possibility of participating in other studies.
Where it's running
-
IRCCS Ospedale San Raffaele
Milan, Milano, Italy Recruiting
Study contacts
- Principal investigator: Fabio Ciceri, MD — IRCCS Ospedale San Raffaele
- Study coordinator: Fabio Ciceri, MD
- Email: ciceri.clinicaltrials@hsr.it
- Phone: +39 02-2643-3093
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.