This pilot randomized Phase II trial (10 subjects per arm) will compare immune reconstitution following transplantation of an autologous mobilized graft product to reconstitution following transplantation of a mobilized graft product followed by an autologous lymphocyte infusion collected prior to G-CSF mobilization. All subjects will receive tetanus vaccines pre and post-transplant. The primary end point will be tetanus vaccine immune responses post-transplant.
PRIMARY OBJECTIVES: 1. To compare the cellular and humoral vaccine response post-transplant between the two arms by performing Elisa, and T-cell enzyme-linked immunospot (ELISPOT) assays 2. To determine the feasibility and safety of this approach SECONDARY OBJECTIVES: 1. To compare post-transplant recovery of innate and adaptive immune cells (CD8, CD4, CD19, NK, γδ T-cells), in addition to T-cell phenotype markers between the two arms. 2. To compare post-transplant recovery of T-regs and MDSCs between the two arms. 3. To compare progression free survival (PFS) at 2 years post-transplant
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
University of Nebraska Medical Center
Omaha, Nebraska, United States
Number of Safely Treated Participants (Feasibility and Safety)
Determine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool
Time frame: Through 180 days post-transplant
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Undergo autologous CD34 HSCT
Given IM