Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways

NCT05124288 | Recruiting

• 1 other identifier: GITMO-RELAPSE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective and prospective non-interventional multicenter observational study. Neither diagnostic approaches nor experimental drugs/procedure will be applied and the samples will take place at the same time as the samples will be taken during routinary clinical practice. The aim of this study is to analyze the immunobiology of Acute Myeloid Leukemia (AML) relapses after allogeneic HSCT for the generation of guidelines and personalized therapeutic pathways.

Conditions

Acute Myeloid Leukemia, in Relapse

Keywords

Haematopoietic Stem Cell Transplantation; Graft versus Host Disease; Acute Myeloid Leukemia; Human Leukocyte Antigens loss

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  The probability of disease-free survival will be calculated from the transplant infusion time to the date of death, last follow-up and / or disease recurrence / progression.

  From date of transplant infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years

Study Arms (1)

Acute Myeloid Leukemia relapsed patients

Adult patients (\< 18 years old), 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).

Other: Observations on Relapsed AML Allogeneic Transplanted patients

Interventions

Observations on Relapsed AML Allogeneic Transplanted patients OTHER

This is not an interventional clinical study. This is a retrospective/prospective observational study on Relapsed AML Allogenic Transplanted patients. Additional samples will be collected during the standard practice.

Acute Myeloid Leukemia relapsed patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort of this study will be composed of adult patients with Acute Myeloid Leukemia, who will relapse after allogeneic transplantation from either familial or unrelated donor, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood). The samples of interest are those taken at the time of post-transplant recurrence at the same time as routine investigations and may be of both medullary blood and peripheral blood, as long as the samples have a percentage of pathological cells equal to at least 5% of cellularity.

You may qualify if:

• 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.

You may not qualify if:

• Participation in clinical protocols that expressly exclude the possibility of participating in other studies.

Sponsors & Collaborators

• Ciceri Fabio: lead
• Gruppo Italiano Trapianto di Midollo Osseo: collaborator
• Associazione Italiana per la Ricerca sul Cancro: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral and bone marrow blood, withdrawn during clinical practice

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Fabio Ciceri, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Ciceri, MD

CONTACT

+39 02-2643-3093; ciceri.clinicaltrials@hsr.it

Stefania Trinca

CONTACT

+39 02-2643-4289; regolatorio.scp@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor and Head of Hematology

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 17, 2021
• Study Start: July 18, 2022
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

IT (1)