Actively Recruiting

Age: 18Years +
All Genders
ID05124288

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

Led by Ciceri Fabio · Updated on 2025-05-13

500

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

C

Ciceri Fabio

Lead Sponsor

G

Gruppo Italiano Trapianto di Midollo Osseo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the immunobiology of relapses in Acute Myeloid Leukemia (AML) following allogeneic hematopoietic stem cell transplantation (HSCT). This observational study aims to analyze disease recurrence mechanisms to help develop guidelines and personalized treatment plans for patients. The study is both retrospective and prospective, involving multiple centers, and does not involve any experimental drugs or diagnostic procedures beyond routine clinical practice. Participants include adult patients with AML who experience relapse after allogeneic HSCT from family or unrelated donors. The study collects data and biological samples during standard clinical care without any intervention, focusing on understanding the role of the tumor microenvironment and gene expression changes in relapse. The study promotes standardizing therapeutic management and supports future innovative clinical studies. During the study, researchers will gather clinical data and biological samples alongside routine care. They will evaluate progression-free survival from transplant infusion until disease progression or death, monitored for up to 20 years. The study involves no additional treatments or procedures beyond usual care, aiming to improve understanding of relapse to enhance patient survival through better-targeted therapies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with Acute Myeloid Leukemia who relapse after allogeneic transplantation from family or unrelated donors
  • Patients who have signed informed consent for the study
  • Patients with stored samples available in a biobank, with prior consent for sample storage according to center practice
Not Eligible

You will not qualify if you...

  • Participation in clinical protocols that do not allow participation in other studies

AI-Screening

AI-Powered Screening

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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)

Monitoring

Duration - Up to 20 years

Participants who have relapsed AML after allogeneic transplantation are observed through collection of clinical data and biological samples during their routine care.

Additional sample collections may occur during standard clinical practice

Trial Site Locations

Total: 1 location

1

IRCCS Ospedale San Raffaele

Milan, Milano, Italy, 20132

Actively Recruiting

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Research Team

F

Fabio Ciceri, MD

S

Stefania Trinca

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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