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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

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
Safety of infection-specific T-cell infusion and vaccination [ Time Frame: 1 week ]
Presence of acute infusion related toxicities
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
Safety of infection-specfic T-cell infusion and vaccination [ Time Frame: 1 week ]
Presence of acute infusion related toxicities
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
  • 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) ]
  • 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) ]
  • Use of specific anti-viral pharmacotherapy [ Time Frame: 12 months (post T-cell infusion) ]
  • Use of systemic anti-fungal drugs including amphotericin and azoles [ Time Frame: 12 months (post T-cell infusion) ]
  • Incidences of GVHD [ Time Frame: 12 months (post T-cell infusion) ]
  • Number of in-hospital days following first discharge post transplant [ Time Frame: 12 months (post T-cell infusion) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
  • Change in infection specfic immune reconstitution [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months (post T-cell infusion) ]
  • 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) ]
  • Use of specific anti-viral pharmocotherapy [ Time Frame: 12 months (post T-cell infusion) ]
  • Use of systemic anti-fungal drugs including amphotericin and azoles [ Time Frame: 12 months (post T-cell infusion) ]
  • Incidences of GVHD [ Time Frame: 12 months (post T-cell infusion) ]
  • Number of in-hospital days following first discharge post transplant [ Time Frame: 12 months (post T-cell infusion) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Infusion of Cytotoxic T-Lymphocytes and Vaccination
Official Title  ICMJE Combined Infusion of Cytotoxic T-Lymphocytes and Vaccination to Enhance Infection-Specific Immune Reconstitution Post-Allogeneic Stem Cell Transplantation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Complication of Transplant
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: T-cell infusion
Infusion of donor-derived T cells. Non randomised, prevention study arm
Intervention: Biological: T-cell infusion, influenza vaccination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 22, 2016)
12
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843321
Other Study ID Numbers  ICMJE Cyntax
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Gottlieb, University of Sydney
Study Sponsor  ICMJE University of Sydney
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Gottlieb, Professor Westmead Hospital
PRS Account University of Sydney
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP