Naive T-Cell Depleted DLI Following Allo Stem Cell Transplant
|ClinicalTrials.gov Identifier: NCT01627275|
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematological Malignancies||Biological: Naive T Cell Depleted Donor Lymphocyte Infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Naive T-Cell Depleted Donor Lymphocyte Infusion Following Allogeneic Stem Cell Transplantation|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||February 24, 2017|
|Actual Study Completion Date :||August 3, 2017|
Experimental: DLI from HLA-identical donor
Naive T Cell Depleted Donor Lymphocyte Infusion from HLA matched family member donor or 8/8 HLA matched unrelated donor.
Biological: Naive T Cell Depleted Donor Lymphocyte Infusion
A single naive T-cell depleted donor lymphocyte infusion will be administered through a peripheral or central venous catheter greater than or equal to 60 days post allogeneic hematopoietic stem cell transplant.
Other Name: CD45RA+ T Cells
- MTD of Naive TCD DLI [ Time Frame: 12 months ]To determine the maximum tolerated dose (MTD) of a Naive T cell depleted (TCD) donor lymphocyte infusion (DLI) post alemtuzumab-containing allogeneic transplant procedure from a HLA-identical family donor, or an 8/8 HLA-matched unrelated donor and derive a preliminary assessment of the efficacy of the naive T-cell depleted DLI.
- Immunological Recovery [ Time Frame: 12 months ]Immunological recovery will be assessed by the immune function panel which consists of a standardized panel of T-cell, B-cell, NK-cell, and dendritic cell antibodies, measurement of T-cell function, analysis of B-cell recovery, quantification of Naive T-cell recovery and a T-cell repertoire assay.
- Overall Incidence of Acute GVHD [ Time Frame: 60 Days ]To assess the overall incidence of Acute Graft Versus Host Disease
- Overall Incidence of Opportunistic Infections [ Time Frame: 60 Days ]To assess the overall incidence of opportunistic infections
- Overall Incidence of Chronic GVHD [ Time Frame: 12 months ]To assess overall incidence of Chronic Graft Versus Host Disease
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627275
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Mitchell Horwitz, MD||Duke University|