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Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
Sponsor: Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Summary
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2025-02-13
Completion Date
2028-06
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Locations (3)
Saint Anna Kinderspital
Vienna, Austria
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy
Azienda Ospedaliera Università Padova
Padova, PD, Italy