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

NCT07552649 | Not Yet Recruiting Phase 2

• 1 other identifier: MATCH-Treg
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

AML (Acute Myeloid Leukemia)

Keywords

allogeneic stem cell transplantation; adoptive immunotherapy; Treg; high-risk AML

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (7)

• Number of participants that have reached engraftment 45 days after HSCT

  45 days

• Number of participants that developed grade ≥ 2 acute GvHD

  100 days

• Number of participants free from chronic GvHD 2 years after HSCT

  2 years

• Number of participants who died for transplant related mortality after HSCT

  2 years

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

  2 years

Study Arms (1)

Myeloablative contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation

EXPERIMENTAL

All enrolled patients will receive a myeloablative conditioning regimen followed by the infusion of HLA-matched donor graft and Treg/Tcon adoptive immunotherapy

Biological: HSCT with Treg/Tcon adoptive immunotherapy

Interventions

HSCT with Treg/Tcon adoptive immunotherapy BIOLOGICAL

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

Myeloablative contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Antonio Pierini: lead

Study Sites (2)

Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia

Perugia, 06132, Italy

Location

Presidio Ospedaliero Pescara - Azienda Sanitaria Locale di Pescara

Pescara, 65124, Italy

Location

Related Publications (4)

• 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.

  PMID: 33646302 BACKGROUND

• 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.

  PMID: 24923299 BACKGROUND

• 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.

  PMID: 21292771 BACKGROUND

• 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.

  PMID: 17095616 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Antonio Pierini

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Pierini

CONTACT

+39 075 578 4147; antonio.pierini@unipg.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (2)