Naive T-Cell Depleted DLI Following Allo Stem Cell Transplant
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|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
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): NCT01627275
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Mitchell Horwitz, MD||Duke University|