Irradiation-based Myeloablative Conditioning Followed by Treg/Tcon Immunotherapy in HSCT



Sponsor:   University Of Perugia


Sommario: 
      To evaluate if hyper-fractionated TBI or TMLI followed by Treg/Tcon adoptive immunotherapy
      improve cGvHD/disease free survival after allogeneic HSCT in patients affected by high-risk
      acute leukemias or other hematologic malignancy where HSCT is indicated.
    




TIPOLOGIA STUDIO

 
Interventistico



FASE

 
Fase 2




TRATTAMENTO

  
    
  






OBIETTIVO PRIMARIO


  
  • Misura: chronic GvHD/relapse-free survival
  • Tempo: 2 years
  • Descrizione: To evaluate if irradiation based myeloablative conditioning followed by Treg/Tcon adoptive immunotherapy improve chronic GvHD/relapse-free survival (GRFS) after allogeneic HSCT in patients affected by acute leukemias or other hematologic malignancies where HSCT is indicated. GRFS will be assessed in subgroups of patients separated according to HLA-matching with the donor and type of disease (acute myeloid lekemia, acute lymphoid leukemia, other)




OBIETTIVO SECONDARIO


  
  • Misura: full donor-type engraftment
  • Tempo: 30 days
  • Descrizione: neutrophil and platelet engraftment measured by neutrophil counts >500/mmc for 3 consecutive days and platelets count >20000/mmc with 7 consecutive without platelet transfusion




CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    
        Inclusion Criteria:

          -  AML and ALL in complete remission and with high-risk of relapse

          -  AML and ALL primarily chemoresistant or relapsed;

          -  Chronic Myeloid Leukemia in accelerated or blastic phase;

          -  Patients affected by

               -  Multiple myeloma,

               -  Non Hodgkin lymphoma,

               -  Hodgkin lymphoma,

               -  Chronic myeloproliferative syndrome,

               -  Chronic Lymphoid Leukemia,

               -  Other Hematological malignancy at high-risk of relapse or detectable disease and
                  where a HSCT is indicated.

          -  Age <75 years

          -  ECOG ≤ 2

          -  Acceptable lung, liver, kidney, and heart function and absence of relevant psichiatric
             diseases

          -  Signature of the informed consent

        Exclusion Criteria:

          -  Age >75 years

          -  ECOG > 2

          -  Not acceptable lung, liver, kidney, and heart function and presence of relevant
             psichiatric diseases

          -  Pregnancy

          -  No signature of the informed consent
      
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: N/A

Età Massima: 75 Years






LUOGO


  
University of Perugia
Perugia, 06132
Contatto:  Antonio Pierini, MD, PhD

      


    
REFERENTE PER INFORMAZIONI

    

      Antonio Pierini, MD, PhD
      +390755784147
      antonio.pierini@unipg.it