Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorIRCCS San Raffaele
Academic / other
Locations1 site (Milan, Milano)
StatusRecruiting
StartedJuly 18, 2022
Main results expectedDecember 20, 2026
Study endsJune 20, 2027
Registry record updatedMay 13, 2025
Trial IDNCT05124288 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.