Adoptive Immunotherapy for CMV Disease - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00159055

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 I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

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

Contacts

Contact: Shimon Slavin, MD	+972-2-6776561	slavin@hadassah.org.il
Contact: Reuven Or, MD	+972-2-6778352	reuvenor@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD +972-2-6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD +972-2-6777572 lhadas@hadassah.org.il
Principal Investigator: Shimon Slavin, MD

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Shimon Slavin, MD

Hadassah Medical Organization

More Information

Study ID Numbers:	280303-HMO-CTIL
Study First Received:	September 9, 2005
Last Updated:	December 12, 2005
ClinicalTrials.gov Identifier:	NCT00159055
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on February 06, 2009