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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

Recruitingn/aAges any - anyAllFondazione Matilde Tettamanti Menotti De Marchi O…
NCT07899840 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients who undergo first HSCT for ALL * Signing of informed consent by the patient (age\>18) or by parent/legal guardian (age \<18) Exclusion Criteria: * Lack of informed consent * \>1° HSCT * ALL with specific genetic backgrounds which may impact on IR such as Down syndrome
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What it tests

  • Not listed
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Where

3 sites
Saint Anna Kinderspital
Vienna, Austria
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Azienda Ospedaliera Università Padova
Padova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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