Ireland
--:--IST
Starting soon Phase 2

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

NCT07552649 · tracked via the Priya Life Science Italy tracker
Sponsor
Antonio Pierini
Phase
Phase 2
Started
2026-04
Last updated
2026-04-27

Condition(s) studied

AML (Acute Myeloid Leukemia)

Investigational drug(s) / intervention(s)

HSCT with Treg/Tcon adoptive immunotherapy

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants free from disease 2 years after HSCT — 2 years
    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.

Trial sites (2)

FacilityCityRegionStatus
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia Perugia Italy
Presidio Ospedaliero Pescara - Azienda Sanitaria Locale di Pescara Pescara Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07552649 on ClinicalTrials.gov ↗ ← All trials in Italy