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Combined Infusion of Cytotoxic T-Lymphocytes and Vaccination (CYNTAX)

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: NCT02843321
Recruitment Status : Unknown
Verified November 2016 by David Gottlieb, University of Sydney.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
David Gottlieb, University of Sydney

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Complication of Transplant Biological: T-cell infusion, influenza vaccination Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Infusion of Cytotoxic T-Lymphocytes and Vaccination to Enhance Infection-Specific Immune Reconstitution Post-Allogeneic Stem Cell Transplantation
Study Start Date : August 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: T-cell infusion
Infusion of donor-derived T cells. Non randomised, prevention study arm
Biological: 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)




Primary Outcome Measures :
  1. Safety of infection-specific T-cell infusion and vaccination [ Time Frame: 1 week ]
    Presence of acute infusion related toxicities


Secondary Outcome Measures :
  1. Change in infection specific immune reconstitution [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months (post T-cell infusion) ]
  2. Change in CMV, EBV and BKV load based on quantitive PCR [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months (post T-cell infusion) ]
  3. Use of specific anti-viral pharmacotherapy [ Time Frame: 12 months (post T-cell infusion) ]
  4. Use of systemic anti-fungal drugs including amphotericin and azoles [ Time Frame: 12 months (post T-cell infusion) ]
  5. Incidences of GVHD [ Time Frame: 12 months (post T-cell infusion) ]
  6. Number of in-hospital days following first discharge post transplant [ Time Frame: 12 months (post T-cell infusion) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02843321


Locations
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Australia, New South Wales
Westmead Hospital Department of Haematology
Westmead, Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
University of Sydney
Investigators
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Principal Investigator: David Gottlieb, Professor Westmead Hospital
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Responsible Party: David Gottlieb, Professor, University of Sydney
ClinicalTrials.gov Identifier: NCT02843321    
Other Study ID Numbers: Cyntax
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Gottlieb, University of Sydney:
infection
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs