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Trial record 3 of 11 for:    r3 stem cell

Partially HLA-matched Third Party Antigen Specific T-cells for Infection Post-stem Cell or Solid Organ Transplantation (R3ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02779439
Recruitment Status : Unknown
Verified July 2016 by David Gottlieb, University of Sydney.
Recruitment status was:  Recruiting
First Posted : May 20, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
David Gottlieb, University of Sydney

Brief Summary:
To assess the safety and biological efficacy of therapeutically administered most closely HLA-matched third party donor-derived specific cytotoxic T lymphocytes (CTLs) targeting cytomegalovirus (CMV) or Adenovirus (Adv) or Epstein Barr virus (EBV) or fungi including Aspergillus and Candida species for the treatment of viral infection following allogeneic blood or marrow stem cell or solid organ transplantation.

Condition or disease Intervention/treatment Phase
CMV Infection EBV Adenovirus Biological: Virus specific CTLs Phase 1

Detailed Description:

The study will analyse the safety and biological efficacy of administering the investigational products (most closely HLA-matched third party donor-derived T cells stimulated with viral or fungal antigen expressing DC), for the treatment of viral reactivation and/or infection or fungal infection following allogeneic blood or marrow or solid organ transplantation. The cells will be given therapeutically after transplantation in patients with active viral reactivation or proven/probably fungal infection despite standard therapy.

Our AIMS are to study the safety of third party donor-derived CTL infusions, their effect on treatment of viral reactivation as well as their effect on reconstitution of virus- and fungus-specific immunity, viral and fungal infection and reactivation rates after transplantation, viral load, and use of antiviral and antifungal pharmacotherapy.

We will evaluate the safety of infusions with respect to the development of adverse events within the first 12 months post-CTL infusion and the dynamics of cell persistence by T-cell chimerism analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Infusion of Partially HLA-matched Third Party Donor-derived Virus- and Fungus Specific T-lymphocytes in Patients With Active Viral or Fungal Infection Post-allogeneic Stem Cell or Solid Organ Transplantation
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: 3rd party CTL infusion
Virus specific CTLs
Biological: Virus specific CTLs
Virus specific CTLs will be given to patients with persistent or recurrent viral reactivation after 2 weeks of standard anti-viral therapy
Other Name: T cells




Primary Outcome Measures :
  1. Infusion related safety [ Time Frame: 1 week ]
    infusion related adverse events



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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recipients of myeloablative or non-myeloablative allogeneic or solid organ transplantation for any indication.
  • Presence of viral reactivation or infection with CMV, Adv or EBV or invasive fungal disease must be present at the time of infusion as determined by:

    • For CMV CMV detectable by antigen detection, PCR or culture in peripheral blood or tissue biopsy or by immunohistochemical staining on tissue biopsy specimen
    • For Adv Presence of Adv as detected by PCR, antigen detection or culture in body fluids including blood, stool, urine or nasopharyngeal secretions
    • For EBV Elevated EB virus detectable in peripheral blood by PCR or Presence of documented EBV related PTLD diagnosed by tissue biopsy or Elevated EB virus detectable in the blood by PCR and clinical or imaging findings consistent with EBV lymphoma
    • For invasive fungal disease Proven or probable invasive fungal disease according to De Pauw 2008[114]
  • Failure of standard therapy as defined by:

    • For CMV The continued presence of detectable CMV virus or antigen after at least 14 days of antiviral therapy with IV ganciclovir or foscarnet Recurrence of detectable CMV virus or antigen after at least 2 weeks of prior antiviral therapy
    • For Adv A rise or less than 50% reduction in viral load in blood or any site of disease as measured by PCR or any quantitative assay despite use of therapy as determined by the treating physician; Standard therapy may include intravenous cidofovir within the limits of renal function
    • For EBV Increase or less than 50% decrease in the size of EBV lymphoma or

Increase or less than 50% decrease in the EBV viral load in peripheral blood despite use of appropriate therapy as determined by the treating physician which may include:

  • Reduction in immunosuppression
  • Rituximab 375mg/m2 up to 4 infusions
  • Cytotoxic chemotherapy

    o For invasive fungal disease inadequate or incomplete clinical response according to treating physician after at least 5 days of best available therapy

  • 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)
  • ECOG status 0 to 3 or Lansky score 30-100
  • 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 methylprednisolone at a dose of > 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion.
  • ECOG status 4 or Lansky score <30
  • Privately insured in or outpatients in New South Wales participating centres (see 12.5 Indemnity issues).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779439


Contacts
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Contact: David Gottlieb, MD FRACP david.gottlieb@sydney.edu.au

Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Sydney, New South Wales, Australia, 2145
Contact: David Gottlieb, MD FRACP       david.gottlieb@sydney.edu.au   
Sponsors and Collaborators
University of Sydney
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Gottlieb, Professor David Gottlieb, University of Sydney
ClinicalTrials.gov Identifier: NCT02779439    
Other Study ID Numbers: R3ACT
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Cytomegalovirus Infections
Disease Attributes
Pathologic Processes
DNA Virus Infections
Virus Diseases
Herpesviridae Infections