Acute Lymphobkastic LeukemiaFlow HSCT IR fNCT07899840
Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
An observational study of Acute Lymphobkastic Leukemia, run by Fondazione Matilde Tettamanti Menotti De Marchi Onlus at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphobkastic Leukemia
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Feb 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing their first HSCT for ALL
Who may be able to join
- 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 join
- Lack of informed consent
- >1° HSCT
- ALL with specific genetic backgrounds which may impact on IR such as Down syndrome
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
Silvia Nucera, MD, +39 0392332229, silvia.nucera@irccs-sangerardo.it
Adriana C Balduzzi, MD
- Recruiting
Azienda Ospedaliera Università Padova
Padova, PD, 35128
Chiara Mainardi, MD, +39 0498218016, chiara.mainardi@aopd.veneto.it
Chiara Mainardi, MD
Austria1 site, 1 recruiting
- Recruiting
Saint Anna Kinderspital
Vienna
Herbert Pichler, MD, +43 1401709305, herbert.pichler@stanna.at
Herbert Pichler, MD
About this study
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.
- Conditions
- Acute Lymphobkastic Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow cytomtetric assessment of post transplant immune reconstitution
Development of a standardized pipeline for longitudinal analysis of identified immune cell subsets.
Measured: From enrollment to 18 months post transplant
Secondary outcomes (2)
Flow cytomtetric analysis of post transplant immune reconstitution
Correlation between identified immune cell subsets and the development of post-HSCT complications
Measured: From enrollment to 18 months post transplant
RNA sequencing validation
Functional validation of data obtained by flow cytometry via RNA sequencing of specific populations of interest.
Measured: From enrollment to 18 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start13 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphobkastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899840
- Sponsor's protocol ID
- ID 4912
- Acronym
- Flow HSCT IR f
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07899840
- Acronym / sponsor ID
- Flow HSCT IR f / ID 4912
- Conditions
- Acute Lymphobkastic Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi OnlusUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing their first HSCT for ALL
Key inclusion criteria (2 listed)
- Patients who undergo first HSCT for ALL
- Signing of informed consent by the patient (age>18) or by parent/legal guardian (age <18)
Key exclusion criteria (3 listed)
- Lack of informed consent
- >1° HSCT
- ALL with specific genetic backgrounds which may impact on IR such as Down syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flow cytomtetric assessment of post transplant immune reconstitution
Time frame: From enrollment to 18 months post transplant
Development of a standardized pipeline for longitudinal analysis of identified immune cell subsets.
2 secondary outcomes
Flow cytomtetric analysis of post transplant immune reconstitution
Time frame: From enrollment to 18 months post transplant
RNA sequencing validation
Time frame: From enrollment to 18 months post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphobkastic Leukemia, run by Fondazione Matilde Tettamanti Menotti De Marchi Onlus at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow cytomtetric assessment of post transplant immune reconstitution (time frame: From enrollment to 18 months post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.