Cytomegalovirus Infection Clinical Trial
Official title:
Phase I/II: Treatment of Adenovirus and Cytomegalovirus Infection Post Human Allogeneic Stem Cell Transplantation With Short-term Expanded Virus-specific T Cells
Invasive infections with CMV and Adenovirus, not responding to virostatic treatment are treated with virusspecific donor derived or autologous virusspecific T-cells.
Allogeneic hematopoietic stem cell transplantation (HSCT) is the only treatment option for
several haematological diseases. In spite of substantial progress in this field, viral
infections, mainly cytomegalovirus (CMV) and adenovirus (HAdV) in the context of delayed
immunoreconstitution remain life threatening complications. Weekly screening of high-risk
patients and preemptive virostatic treatment has become a current strategy. Unfortunately,
treatment with virostatic drugs is associated with substantial nephro- and myelo-toxicity and
of limited effectiveness. Human adenovirus (HAdV) and cytomegalvirus (CMV) disseminated
infections are associated with mortality rates of up to 50%-60% despite virostatic treatment.
All HSCT patients at the St. Anna Children's Hospital undergo weekly viral quantitative
PCR-screening for HAdV and CMV and weekly PB FACS (Fluorescence Activated Cell
Sorter)-Analysis according to the local HSCT-diagnostic SOP (Standard Operating Procedure)
from day -7 until day +100 Patients with HAdV or CMV viremia will receive preemptive
treatment with either gancyclovir (in case of isolated CMV-viremia) or Cidofovir (in case of
HAdV viremia or combined HAdV/CMV infection). In case of increasing viremia ≥ 1log despite
antiviral treatment for two weeks or stable with 10E6 viral load and the absence of virus
specific T-cells in the recipient, the treating physician will check, if the patient is
eligible for seVirus-T-cell infusion (see inclusion criteria).
Study Design: Mononuclear Donor-Cells from peripheral blood (100 ml extra donation) will be
cryopreserved at the time-point of HSCT. In case of progredient viremia these cells will be
stimulated with interleukin-15 and peptides out of the virus molecule, virusspecific T-Cells
are enriched for 2-3 logs-teps and potentially alloreactive cells diluted at the same time.
This new approach reduces the risk of graft-versus-host-disease (GvHD) and enables the
infusion of virus-specific T-cells also from haploidentical donors.
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