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Adoptive Immunotherapy for CMV Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159055
Recruitment Status : Withdrawn (the PI is no longer work at Hadassah)
First Posted : September 12, 2005
Last Update Posted : April 8, 2011
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
CMV Disease Biological: CMV vaccine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 2004

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

Secondary Outcome Measures :
  1. Evaluate toxicity of the procedure.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00159055

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

Layout table for additonal information Identifier: NCT00159055     History of Changes
Other Study ID Numbers: 280303-HMO-CTIL
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: September 2005