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

University Of Perugia

Status and phase: Unknown; Phase 2

Conditions: Multiple Myeloma; Other Hematologic Malignant Neoplasms; Acute Lymphoid Leukemia; Myeloproliferative Disorders; Lymphoma; Acute Myeloid Leukemia

Treatments: Biological: High dose irradiation conditioning + Treg/Tcon

Study type: Interventional

Funder types: Other

Identifiers

NCT03977103

02/14

Details and patient eligibility

About

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.

Full description

Improving cGvHD/disease free survival in patients with high-risk acute leukemias or other hematologic malignancy where HSCT is indicated with 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 a purified CD34+ hematopoietic stem cell graft. 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 in patient subpopulations separated according to HLA-matching with the donor (HLA-matched HSCT and HLA-haploidentical HSCT) and type of disease (acute myeloid leukemia, acute lymphoid leukemia, lymphoma, multiple myeloma, myeloproliferative disease, and other).

Enrollment: 80 estimated patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

High dose irradiation conditioning + Treg/Tcon

Experimental group

Description:

High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation

Treatment:

Biological: High dose irradiation conditioning + Treg/Tcon