Adoptive Immunotherapy for CMV Disease

This study has been withdrawn prior to enrollment.
(the PI is no longer work at Hadassah)
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00159055
First received: September 9, 2005
Last updated: April 7, 2011
Last verified: September 2005
  Purpose

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 Intervention Phase
CMV Disease
Biological: CMV vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.

Secondary Outcome Measures:
  • Evaluate toxicity of the procedure.

Estimated Enrollment: 20
Study Start Date: February 2004
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For Patient:
  • Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
  • Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
  • Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
  • Patients with HLA phenotype for which a relevant peptide for CMV exists.
  • For Donor:
  • Consenting sibling >18 years old.
  • HLA phenotype for which a relevant peptide for CMV exists.

Exclusion Criteria:

  • For Patient:
  • Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
  • For Donor:
  • Consenting sibling >18 years old.
  • HLA phenotype for which a relevant peptide for CMV exists.
  • Donor with an infectious disease (e.g. HIV-1; HBV, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159055

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159055     History of Changes
Other Study ID Numbers: 280303-HMO-CTIL
Study First Received: September 9, 2005
Last Updated: April 7, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on August 28, 2014