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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02700841
Study type Interventional
Source University of Nebraska
Contact
Status Terminated
Phase Phase 2
Start date January 9, 2020
Completion date December 21, 2022

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