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NCT07899840Recruiting

Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
20 Oct 2026
Start date
13 Feb 2025
Primary completion date
Dec 2026
Lead sponsor
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
NCT number
NCT07899840

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 13 Feb 2025 to the primary completion date, Dec 2026
  • 3 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • ALL with specific genetic backgrounds which may impact on IR such as Down syndrome

Other

  • Lack of informed consent
  • \>1° HSCT

Who the study is looking for

  • Patients who undergo first HSCT for ALL
  • Signing of informed consent by the patient (age\>18) or by parent/legal guardian (age \<18)

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Saint Anna Kinderspital
Coordinator of this site? Confirm its status
ViennaAustriaRecruiting
Fondazione IRCCS San Gerardo dei Tintori
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
Azienda Ospedaliera Università Padova
Coordinator of this site? Confirm its status
PadovaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.