An observational study in Acute Lymphobkastic Leukemia, sponsored by Fondazione Matilde Tettamanti Menotti De Marchi Onlus. Recruiting at 3 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Fondazione Matilde Tettamanti Menotti De Marchi Onlus · Observational
Primary Objective
To assess immune reconstitution during the first 18 months following hematopoietic stem cell transplantation (HSCT) for acute lymphoblastic leukemia (ALL), with a particular focus on the T-cell compartment (thymic regeneration and surrogate markers of cytotoxic function), using a dedicated panel developed within the EuroFlow consortium.
Secondary Objectives
To assess the impact of donor and recipient characteristics, graft-versus-host disease (GvHD) prophylaxis, and conditioning regimen on post-transplant immune reconstitution.
To evaluate the correlation between immune reconstitution and the development of complications using unsupervised analysis.
Fondazione Matilde Tettamanti Menotti De Marchi Onlus is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing their first HSCT for ALL
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Flow cytomtetric assessment of post transplant immune reconstitution
Development of a standardized pipeline for longitudinal analysis of identified immune cell subsets.
Time frame: From enrollment to 18 months post transplant
Flow cytomtetric analysis of post transplant immune reconstitution
Correlation between identified immune cell subsets and the development of post-HSCT complications
Time frame: From enrollment to 18 months post transplant
RNA sequencing validation
Functional validation of data obtained by flow cytometry via RNA sequencing of specific populations of interest.
Time frame: From enrollment to 18 months post transplant
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fondazione Matilde Tettamanti Menotti De Marchi Onlus