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AzTrials

AML (Acute Myeloid Leukemia)Phase 2MATCH-TregNCT07552649

Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia

A Phase 2 study testing HSCT with Treg/Tcon adoptive immunotherapy in people with AML (Acute Myeloid Leukemia), run by Antonio Pierini at 2 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The study is a multicentric, interventional study that evaluates the efficacy of allogeneic HLA-matched allo-HSCT consisting of myeloablative conditioning coupled with donor Treg/Tcon adoptive immunotherapy for high-risk AML patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
AML (Acute Myeloid Leukemia)
What is being tested?
HSCT with Treg/Tcon adoptive immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesItaly
Study dates
Apr 2026to Apr 2030
Phase
Phase 2
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of AML with adverse genetic mutations in Complete Remission (CR) or incomplete (i) CR according to ELN 2022 recommendations with or without MRD positivity at the time of the HSCT procedure;
  • Diagnosis of AML with intermediate genetic mutations in Complete remission (CR) or incomplete (i) CR according to ELN 2022 with MRD positivity at the time of the transplant;
  • Fitness to undergo allo-HCT with myeloablative conditioning regimens according to center policy;
  • Availability of a family HLA-matched hematopoietic stem cell donor suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
  • Age ≥ 18 and ≤ 70 years
  • ECOG ≤ 2
  • HCT-CI ≤ 4
  • Signature of the informed consent

Who cannot join

  • Prior allo-HSCT
  • AML with favorable genetic abnormalities
  • AML with intermediate genetic risk with MRD negativity
  • Active disease at transplant (> 5% bone marrow infiltration)
  • Availability of a haploidentical or matched unrelated donor (MUD)
  • Age < 18 years or > 70 years
Show all 11Show fewer
  • ECOG > 2
  • Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
  • Uncontrolled bacterial, viral, or fungal infections at time of enrollment
  • Pregnancy
  • No signature of the informed consent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Antonio Pierini contact

+39 075 578 4147

antonio.pierini@unipg.it

Italy2 sites

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia

    Perugia, 06132

    Antonio Pierini, +39 075 578 4147, antonio.pierini@unipg.it

  • Presidio Ospedaliero Pescara - Azienda Sanitaria Locale di Pescara

    Pescara, 65124

    Mauro Di Ianni

Other trials in Italy

About this study

Official title: MATCH-Treg: Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia

The study is a multicentric, interventional study that evaluates the efficacy of allogeneic HLA-matched allo-HSCT consisting of myeloablative conditioning coupled with donor Treg/Tcon adoptive immunotherapy for high-risk AML patients.

Being tested
HSCT with Treg/Tcon adoptive immunotherapy
Keywords
allogeneic stem cell transplantation, adoptive immunotherapy, Treg, high-risk AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSCT with Treg/Tcon adoptive immunotherapyBiological

    Purified CD34+ hematopoietic progenitor cells with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation from HLA-matched related donor

Study groups in NCT07552649
Study groupRoleWhat they receive
Myeloablative contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantationExperimentalAll enrolled patients will receive a myeloablative conditioning regimen followed by the infusion of HLA-matched donor graft and Treg/Tcon adoptive immunotherapy
Receives: Biological: HSCT with Treg/Tcon adoptive immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants free from disease 2 years after HSCT

    The primary objective of the study is to reduce the incidence of disease relapse after myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched donors in high-risk AML patients.

    Measured: 2 years

Secondary outcomes (7)

  1. Number of participants that have reached engraftment 45 days after HSCT

    The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on full donor type engraftment

    Measured: 45 days

  2. Number of participants that developed grade ≥ 2 acute GvHD

    The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on grade ≥ 2 acute GvHD

    Measured: 100 days

  3. Number of participants free from chronic GvHD 2 years after HSCT

    The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on chronic GvHD

    Measured: 2 years

  4. Number of participants who died for transplant related mortality after HSCT

    The study will also evaluate the impact of allo-HSCT from HLA-matched donors with myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy on non relapse mortality (NRM)

    Measured: 2 years

  5. Number of patients free from ≥ 2 acute GvHD and/or moderate/severe chronic GvHD and/or relapse

    The study will also measure grade ≥ 2 acute GvHD and/or moderate/severe chronic GvHD/Relapse-free survival (GRFS)

    Measured: 2 years

  6. Number of patients free from moderate/severe chronic GvHD and relapse

    The study will also measure moderate/severe chronic GvHD-Relapse-free survival (CRFS)

    Measured: 2 years

  7. Number of patients alive after 2 years after allogeneic transplant

    Overall survival (OS) of patients treated with allogeneic transplant

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study is a multicentric, interventional study that evaluates the efficacy of allogeneic HLAmatched allo-HSCT consisting of myeloablative conditioning coupled with donor Treg/Tcon adoptive immunotherapy for high-risk AML patients.
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07552649
Sponsor's protocol ID
MATCH-Treg
Acronym
MATCH-Treg
Status last verified
Apr 2026
First submitted
20 Apr 2026
Last updated
27 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: anonymized IPD will be shared for one year after study completion upon formal and reasonable request

Publications

  • Pierini A, Ruggeri L, Carotti A, Falzetti F, Saldi S, Terenzi A, Zucchetti C, Ingrosso G, Zei T, Iacucci Ostini R, Piccinelli S, Bonato S, Tricarico S, Mancusi A, Ciardelli S, Limongello R, Merluzzi M, Di Ianni M, Tognellini R, Minelli O, Mecucci C, Martelli MP, Falini B, Martelli MF, Aristei C, Velardi A. Haploidentical age-adapted myeloablative transplant and regulatory and effector T cells for acute myeloid leukemia. Blood Adv. 2021 Mar 9;5(5):1199-1208. doi: 10.1182/bloodadvances.2020003739.

    PubMed 33646302

  • Martelli MF, Di Ianni M, Ruggeri L, Falzetti F, Carotti A, Terenzi A, Pierini A, Massei MS, Amico L, Urbani E, Del Papa B, Zei T, Iacucci Ostini R, Cecchini D, Tognellini R, Reisner Y, Aversa F, Falini B, Velardi A. HLA-haploidentical transplantation with regulatory and conventional T-cell adoptive immunotherapy prevents acute leukemia relapse. Blood. 2014 Jul 24;124(4):638-44. doi: 10.1182/blood-2014-03-564401. Epub 2014 Jun 12.

    PubMed 24923299

  • Di Ianni M, Falzetti F, Carotti A, Terenzi A, Castellino F, Bonifacio E, Del Papa B, Zei T, Ostini RI, Cecchini D, Aloisi T, Perruccio K, Ruggeri L, Balucani C, Pierini A, Sportoletti P, Aristei C, Falini B, Reisner Y, Velardi A, Aversa F, Martelli MF. Tregs prevent GVHD and promote immune reconstitution in HLA-haploidentical transplantation. Blood. 2011 Apr 7;117(14):3921-8. doi: 10.1182/blood-2010-10-311894. Epub 2011 Feb 3.

    PubMed 21292771

  • Nguyen VH, Zeiser R, Dasilva DL, Chang DS, Beilhack A, Contag CH, Negrin RS. In vivo dynamics of regulatory T-cell trafficking and survival predict effective strategies to control graft-versus-host disease following allogeneic transplantation. Blood. 2007 Mar 15;109(6):2649-56. doi: 10.1182/blood-2006-08-044529. Epub 2006 Nov 9.

    PubMed 17095616

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSCT with Treg/Tcon adoptive immunotherapy in people with AML (Acute Myeloid Leukemia), run by Antonio Pierini at 2 sites in Italy.

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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Antonio Pierini (+39 075 578 4147, antonio.pierini@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants free from disease 2 years after HSCT (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07552649, which also lists 4 linked publications.

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 27 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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