Testing immune reconstitution after stem cell transplant in adults with acute lymphoblastic leukemia
Official title: Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
Run by Fondazione Matilde Tettamanti Menotti De Marchi Onlus · NCT07899840 · Data updated 2026-11-12
This study tests how the immune system recovers after a stem cell transplant in people with ALL to see if certain immune markers, especially T cells, can predict complications.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fondazione Matilde Tettamanti Menotti De Marchi Onlus Academic / other |
| Locations | 3 sites (Vienna and 2 other locations) |
| Status | Recruiting |
| Started | February 13, 2025 |
| Main results expected | December 2026 |
| Study ends | June 2028 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07899840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (and minors with parental consent) undergoing a first HSCT for ALL who can provide informed consent.
✕Probably not a fit
Patients who do not undergo HSCT or who do not consent to participate may not benefit from study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational effort follows patients after their first hematopoietic stem cell transplant for ALL over 18 months. It uses a standardized flow cytometry panel from the EuroFlow consortium to characterize T-cell recovery and surrogate markers of cytotoxic function. The study also looks at how donor/recipient features, GvHD prevention strategies, and conditioning regimens relate to immune reconstitution and later complications using unsupervised data analysis. No interventions are being tested beyond immune-phenotyping; results may help tailor post-transplant monitoring. Recruitment spans multiple European centers.
Why it matters
Potential benefit: If successful, the study could improve how clinicians monitor immune recovery and potentially predict or prevent transplant-related complications.
How similar studies have gone: Previous work using standardized flow cytometry panels has shown promise in characterizing post-transplant immune reconstitution, supporting the potential value of this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Saint Anna Kinderspital
Vienna, Austria Recruiting -
Fondazione IRCCS San Gerardo dei Tintori
Monza, Mb, Italy Recruiting -
Azienda Ospedaliera Università Padova
Padova, Pd, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.