Not yet recruiting NCT07552649
Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSCT with Treg/Tcon adoptive immunotherapy.
- Who it may be relevant to
- Registry conditions: AML (Acute Myeloid Leukemia). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Number of participants free from disease 2 years after HSCT [Time frame: 2 years]
Secondary outcome measures (7)
- Number of participants that have reached engraftment 45 days after HSCT [Time frame: 45 days]
- Number of participants that developed grade ≥ 2 acute GvHD [Time frame: 100 days]
- Number of participants free from chronic GvHD 2 years after HSCT [Time frame: 2 years]
- Number of participants who died for transplant related mortality after HSCT [Time frame: 2 years]
- Number of patients free from ≥ 2 acute GvHD and/or moderate/severe chronic GvHD and/or relapse [Time frame: 2 years]
- Number of patients free from moderate/severe chronic GvHD and relapse [Time frame: 2 years]
- Number of patients alive after 2 years after allogeneic transplant [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia — Perugia
- Presidio Ospedaliero Pescara - Azienda Sanitaria Locale di Pescara — Pescara
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 PMID 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- PMID 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-20 PMID 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. PMID 17095616
Identifiers
NCT: NCT07552649 · MATCH-Treg