Adoptive Immunotherapy for CMV Disease

CMV Disease Clinical Trial

Official title:

Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00159055
• Other study ID #: 280303-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: April 7, 2011
• Start date: February 2004

Study information

• Verified date: September 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

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 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.)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CMV Disease

Intervention

Biological:
• CMV vaccine

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.
Secondary	Evaluate toxicity of the procedure.