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Trial record 50 of 1320 for:    Hematologic neoplasm

Treg/Tcon Immunotherapy Combined With High Dose Irradiation in HSCT

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ClinicalTrials.gov Identifier: NCT03977103
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Velardi, University Of Perugia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Haematological Malignancy Biological: High dose irradiation conditioning + Treg/Tcon Phase 2

Detailed Description:
Improving cGvHD/disease free survival in patients with high-risk acute leukemias or other hematologic malignancy where HSCT is indicated whit the use of a regulatory T cell based protocol. Hyper-fractionated Total Body Irradiation or Total Marrow and Lymphoid Irradiation based conditioning will be followed by the infusion of T regulatory and T conventional cell adoptive immunotherapy and the incolum of purified CD34+ hematopoietic stem cells. Incidence of Non Relapse Mortality, Relapse, acute Graft versus Host Disease, chronic Graft versus Host Disease, as well as probability of cGvHD/disease free survival will be assessed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antileukemic Activity of Allogeneic Hematopoietic Stem Cell Transplantation With Hyperfractionated Total Body Irradiation or Total Marrow and Lymph Node Irradiation Followed by Adoptive Immunotherapy With Regulatory and Conventional T Cells
Study Start Date : February 2014
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Arm Intervention/treatment
Experimental: High dose irradiation conditioning + Treg/Tcon
High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation
Biological: High dose irradiation conditioning + Treg/Tcon
High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation




Primary Outcome Measures :
  1. chronic GvHD and disease free survival [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977103


Contacts
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Contact: Antonio Pierini, MD, PhD +390755784147 antonio.pierini@unipg.it
Contact: Mara Merluzzi, MBioTech +393482200239 maramerluzzi@libero.it

Locations
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Italy
University of Perugia Recruiting
Perugia, PG, Italy, 06132
Contact: Antonio Pierini, MD, PhD    +390755784147    antonio.pierini@unipg.it   
Contact: Mara Merluzzi, MBioTech    +393482200239    maramerluzzi@libero.it   
Principal Investigator: Cynthia Aristei, MD         
Principal Investigator: Maurizio Caniglia, MD         
Sub-Investigator: Alessandra Carotti, MD         
Sub-Investigator: Franca Falzetti, MD         
Sub-Investigator: Antonio Pierini, MD         
Sub-Investigator: Loredana Ruggeri, MD         
Sub-Investigator: Adelmo Terenzi, MD         
Sub-Investigator: Simonetta Saldi, MD         
Sub-Investigator: Ilaria Capolsini, MD         
Sub-Investigator: Elena Mastrodicasa, MD         
Sub-Investigator: Maria Speranza Massei, MD         
Sponsors and Collaborators
University Of Perugia
Investigators
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Principal Investigator: Andrea Velardi, MD, PhD University Of Perugia