CMV Disease Clinical Trial
Official title:
Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)
Treatment strategy of patients:
Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative
transplantation tolerance.
Whenever indicated, additional post NST DLI given in graded increment, to optimize control
of GVHD.
Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a
CMV-specific peptide followed by administration of immunized donor lymphocytes, or by
injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient
following DLI.
Pre-emptive treatment of seronegative patients at risk or patients with documented viremia
or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the
host by peptide immunization.
Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs
in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed
with relevant peptides.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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