Tracking immune system recovery after stem cell transplant for acute lymphoblastic leukemia
Studies how the immune system recovers after stem cell transplant for acute lymphoblastic leukemia.
Key facts
- Who runs it
- Fondazione Matilde Tettamanti Menotti De Marchi Onlus
- Where
- Monza and Padova, ItalySee the 2 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 13 Feb 2025
- Expected to end
- Jun 2028
- Type of study
- Observational
- Record updated
- 28 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people having their first stem cell transplant for acute lymphoblastic leukemia (ALL). It tracks how the immune system recovers after the transplant.
- Age
- Adults and children. Adults sign their own consent; for children a parent or legal guardian signs.
- Sex
- All sexes can join.
- Disease stage
- Acute lymphoblastic leukemia (ALL), at the time of a first stem cell transplant.
- Earlier treatment
- This must be the first stem cell transplant. People who already had more than one transplant cannot join.
Main reasons for not taking part
- No informed consent
- More than one stem cell transplant
- ALL with a genetic background that may affect immune recovery, such as Down syndrome
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Patients who undergo first HSCT for ALL
- Signing of informed consent by the patient (age>18) or by parent/legal guardian (age <18)
Who cannot take part
- ALL with specific genetic backgrounds which may impact on IR such as Down syndrome
- Lack of informed consent
- >1° HSCT
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What type of cancer has the patient been diagnosed with?
- Has the patient had Down syndrome (an extra copy of chromosome 21) diagnosed?
Where in Italy
Also in 1 other country, 1 site
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyContact: Silvia Nucera, MDTaking people
- Azienda Ospedaliera Università PadovaPadova, ItalyContact: Chiara Mainardi, MDTaking people
About the trial
What the trial wants to find out
Primary Objective
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
- Plain-language title
- Tracking immune system recovery after stem cell transplant for acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07899840, who can take part
- Record updated
- 28 October 2026