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Combined Infusion of Cytotoxic T-Lymphocytes and Vaccination

NCT ID: NCT02843321

Last Updated: 2016-11-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-12-31

Brief Summary

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To assess the safety and biological efficacy of prophylactically administered donor-derived multi-infection specific cytotoxic T lymphocytes (CTLs) (targeting cytomegalovirus (CMV), Adenovirus (Adv), Epstein Barr virus (EBV), Varicella-Zoster virus (VZV), Influenza (Flu), BK virus (BKV), and Aspergillus (Asp)) combined with early immunisation with Influenza and VZV vaccines for the prevention of viral and fungal infection following allogeneic blood or marrow stem cell transplantation.

Detailed Description

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The study will analyse the safety and biological efficacy of administering the investigational products (donor-derived T cells stimulated with viral and fungal antigen expressing DC combined with Flu and VZV immunisation), for the prophylaxis of viral and fungal reactivation and/or infection following allogeneic blood or marrow transplantation. The cells will be given prophylactically a minimum of 28 days after transplantation followed by administration of the Flu and VZV vaccines 24 to 72 hours later. The AIMS are to study the safety of combining CTL infusions and vaccination as well as their effect on reconstitution of infection-specific immunity, viral and Aspergillus reactivation and infection rates after transplantation, viral load, and use of antiviral and antifungal pharmacotherapy for specific infections. The investigators will also evaluate the safety of infusions and vaccinations with respect to the development adverse events within the first 12 months post transplant.

Conditions

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Complication of Transplant

Keywords

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infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T-cell infusion

Infusion of donor-derived T cells. Non randomised, prevention study arm

Group Type EXPERIMENTAL

T-cell infusion, influenza vaccination

Intervention Type BIOLOGICAL

Donor derived infection-specific T-cells (with activity against CMV,adenovirus, EBV, VZV, Influenza, BKV and Aspergillus) and vaccination (with Fluvax)

Interventions

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T-cell infusion, influenza vaccination

Donor derived infection-specific T-cells (with activity against CMV,adenovirus, EBV, VZV, Influenza, BKV and Aspergillus) and vaccination (with Fluvax)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing myeloablative or non-myeloablative allogeneic transplantation from an HLA (A, B and DR) identical or 1-3 antigen mismatched family or unrelated donor.
* Transplant performed for any type of non-malignant condition or haematological malignancy including but not limited to acute and chronic leukaemia, myelodysplasia, non Hodkgins and Hodgkin lymphoma or myeloma.
* Recipients of peripheral blood or bone marrow stem cells.
* Adequate hepatic and renal function (\< 3 x upper limit of normal for AST (SGOT), ALT (SGPT), \< 2 x upper limit of normal for total bilirubin, serum creatinine).
* Estimated life expectancy of at least 6 months.
* Patient (or legal representative) has given informed consent

Exclusion Criteria

* Use of anti-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum lymphocyte antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks after infusion.
* Grade II or greater graft versus host disease within 1 week prior to infusion.
* Prednisone or methylprednisone at a dose of \> 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion.
* Allergies to eggs or components of the Fluvax or Varivax vaccines.
* Privately insured in or outpatients
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sydney

OTHER

Sponsor Role lead

Responsible Party

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David Gottlieb

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Gottlieb, Professor

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital

Locations

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Westmead Hospital Department of Haematology

Westmead, Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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Cyntax

Identifier Type: -

Identifier Source: org_study_id