Trials / Unknown
UnknownNCT03977103
Irradiation-based Myeloablative Conditioning Followed by Treg/Tcon Immunotherapy in HSCT
Antileukemic Activity of Allogeneic Hematopoietic Stem Cell Transplantation With Fractionated Total Body Irradiation or Total Marrow and Lymph Node Irradiation Followed by Adoptive Immunotherapy With Regulatory and Conventional T Cells
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- University Of Perugia · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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).
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Myeloproliferative Disorders
- Lymphoma
- Multiple Myeloma
- Other Hematologic Malignant Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2023-02-28
- Completion
- 2023-02-28
- First posted
- 2019-06-06
- Last updated
- 2020-01-13
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03977103. Inclusion in this directory is not an endorsement.