Analyzing the immune response in relapsed Acute Myeloid Leukemia after stem cell transplant
Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT05124288 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients with Acute Myeloid Leukemia who have relapsed after allogeneic transplantation.
Not a fit: Patients currently participating in clinical protocols that exclude participation in other studies may not benefit from this study.
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 performed: Other studies have shown promise in analyzing immunobiology in similar contexts, but this specific approach is relatively novel.
Eligibility criteria
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 this trial is running
Milan, Milano
- 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
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.