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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Anna Kinderspital Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Azienda Ospedaliera Università Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.