NCT00159055

Adoptive Immunotherapy for CMV Disease

Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• CMV Disease

Interventions

Type	Name	Description
BIOLOGICAL	CMV vaccine

Timeline

• Start date: 2004-02-01
• First posted: 2005-09-12
• Last updated: 2011-04-08

Locations

1 site across 1 country: Israel