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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCiceri Fabio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Observations on Relapsed AML Allogeneic Transplanted patients

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Acute Myeloid Leukemia relapsed patients1 intervention

Trial outcomes

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.

Time frame
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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciceri Fabio

Lead sponsor

IRCCS San Raffaele

Sponsor institution

Gruppo Italiano Trapianto di Midollo Osseo

Collaborator

Associazione Italiana per la Ricerca sul Cancro

Collaborator