Adoptive Immunotherapy for CMV Disease
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|ClinicalTrials.gov Identifier: NCT00159055|
Recruitment Status : Withdrawn (the PI is no longer work at Hadassah)
First Posted : September 12, 2005
Last Update Posted : April 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|CMV Disease||Biological: CMV vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)|
|Study Start Date :||February 2004|
- Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.
- Evaluate toxicity of the procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159055
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Shimon Slavin, MD||Hadassah Medical Organization|