Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159055
Status:
WITHDRAWN
Last Update Posted:
2011-04-08
First Post:
2005-09-09
Brief Title:
Adoptive Immunotherapy for CMV Disease
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation NST
Status:
WITHDRAWN
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the PI is no longer work at Hadassah
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None