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Clinical Trial: Adoptive Immunotherapy for CMV Disease
This study is currently recruiting patients.
Verified by Hadassah Medical Organization September 2005
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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 | Vaccine: CMV vaccine | Phase I Phase II |
MedlinePlus consumer health information
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)
Secondary Outcomes: Evaluate toxicity of the procedure.
Expected Total Enrollment: 20
Study start: February 2004
Eligibility
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 congentional 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:
Location and Contact Information
Reuven Or, MD +972-2-6778352 reuvenor@hadassah.org.il
Israel
Hadassah Medical Organization, Jerusalem, 91120, Israel; Recruiting
Hadas Lemberg, PhD +972-2-6777572 lhadas@hadassah.org.il
Shimon Slavin, MD, Principal Investigator
Shimon Slavin, MD, Principal Investigator, Hadassah Medical Organization
More Information
Last Updated: September 11, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00159055
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2005-09-13

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