Miami, Florida 33136


Purpose:

The investigators are collecting blood samples to learn more about how the body's immune system recovers after stem cell transplant (SCT). Participants are either previous recipients of a stem cell transplant, or a donor of stem cells for transplant.


Study summary:

The investigators propose to systematically collect specimens of blood and plasma from donors and recipients of SCT. For recipients, samples may be collected at the following time points or transplant milestones. If the recipient is not able to be present at SCCC/UMHC during the window of one of these milestone visits, the specified collection may be missed due to unavailability. The recipient may then resume sample collection at the subsequent collection period. Collections may be received within 30 days prior to transplantation, at approximately 30 days (+/- 7 business days), 60 days (+/- 14 business days), 100 days (+/- 21 business days), six months (+/- 21 business days), one year(+/- 21 business days), and annually(+/- 21 business days) thereafter following SCT. Up to three additional samples, collected no more frequently than weekly, may be collected if recipients experience complications (e.g., viral reactivation) associated with abnormal T cell immune recovery after SCT. A sample may also be removed that is equal to or less than 1% of the total product volume of the donor collection, prior to recipient infusion. For donors, one sample will be collected prior to stem cell mobilization with G-CSF. Assays to be performed may include the following: 1) Functional studies of antigen-specific T cell responses to pathogens (e.g., cytomegalovirus) and to other antigens (e.g., to defined epitopes that have been identified as potential malignancy-specific targets)(8,15); 2) T cell immunophenotyping (to define the recovery of T cell subsets associated with a "naive" or "memory" T cell phenotype)(16,17); 3) Studies examining the molecular diversity of the T cell repertoire(18,19); 4) Studies to identify recent thymic emigrants in the peripheral blood to determine the extent of thymic function occurring at steady state or following BMT(11,20); and 5) Assays of plasma levels of cytokines (e.g., interleukin-7) that may be important in T cell reconstitution(21,22). Some or all of these studies may be performed at the time of collection. In most cases, cryopreserved PBMC or plasma samples will be used for these assays. Cryopreserved cells in excess of requirements for studies of immune reconstitution will be banked to allow access by other investigators to these specimens. By increasing our understanding of immune recovery post-stem cell transplantation, the investigators will be able to develop strategies to improve immune recovery and reduce graft-versus-host disease to be tested in future clinical trials. It is the investigators' goal to develop graft engineering strategies to improve both of those important clinical problems in SCT patients. The purpose of this protocol is to study immune reconstitution and graft-versus- host disease in stem cell transplant recipients, and to study the role of donor cells and the clinical regimen on those processes.


Criteria:

Inclusion Criteria: - Stem Cell Transplant Donor - Stem Cell Transplant Recipient Exclusion Criteria:


NCT ID:

NCT02129543


Primary Contact:

Principal Investigator
Krishna V Komanduri, MD
University of Miami


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States

Krishna Komaduri, MD
Phone: 305-243-6356
Email: kkomanduri@med.miami.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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