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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: AML (Acute Myeloid Leukemia)
• Intervention / Treatment: Biological: HSCT with Treg/Tcon adoptive immunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Antonio Pierini; Phone Number: +39 075 578 4147; Email: antonio.pierini@unipg.it

Study Locations

• Italy
  • Perugia, Italy, 06132
    • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
    • Contact: Antonio Pierini; Phone Number: +39 075 578 4147; Email: antonio.pierini@unipg.it
  • Pescara, Italy, 65124
    • Presidio Ospedaliero Pescara - Azienda Sanitaria Locale di Pescara
    • Contact: Mauro Di Ianni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myeloablative contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation; 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; Purified CD34+ hematopoietic progenitor cells with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation from HLA-matched related donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	45 days
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	100 days
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	2 years
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)	2 years
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)	2 years
Number of patients free from moderate/severe chronic GvHD and relapse	The study will also measure moderate/severe chronic GvHD-Relapse-free survival (CRFS)	2 years
Number of patients alive after 2 years after allogeneic transplant	Overall survival (OS) of patients treated with allogeneic transplant	2 years

Collaborators and Investigators

• Sponsor: Antonio Pierini
• Investigators: Principal Investigator: Antonio Pierini, University Of Perugia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: allogeneic stem cell transplantation; Treg; adoptive immunotherapy; high-risk AML
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: MATCH-Treg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: anonymized IPD will be shared for one year after study completion upon formal and reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No