Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2004-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CMV vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Principal Investigators
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Shimon Slavin, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Other Identifiers
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280303-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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