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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02843321




Registration number
NCT02843321
Ethics application status
Date submitted
18/05/2016
Date registered
25/07/2016
Date last updated
22/11/2016

Titles & IDs
Public title
Combined Infusion of Cytotoxic T-Lymphocytes and Vaccination
Scientific title
Combined Infusion of Cytotoxic T-Lymphocytes and Vaccination to Enhance Infection-Specific Immune Reconstitution Post-Allogeneic Stem Cell Transplantation
Secondary ID [1] 0 0
Cyntax
Universal Trial Number (UTN)
Trial acronym
CYNTAX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complication of Transplant 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - T-cell infusion, influenza vaccination

Experimental: T-cell infusion - Infusion of donor-derived T cells. Non randomised, prevention study arm


Treatment: Other: 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 code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of infection-specific T-cell infusion and vaccination
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Change in infection specific immune reconstitution
Timepoint [1] 0 0
1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months (post T-cell infusion)
Secondary outcome [2] 0 0
Change in CMV, EBV and BKV load based on quantitive PCR
Timepoint [2] 0 0
1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months (post T-cell infusion)
Secondary outcome [3] 0 0
Use of specific anti-viral pharmacotherapy
Timepoint [3] 0 0
12 months (post T-cell infusion)
Secondary outcome [4] 0 0
Use of systemic anti-fungal drugs including amphotericin and azoles
Timepoint [4] 0 0
12 months (post T-cell infusion)
Secondary outcome [5] 0 0
Incidences of GVHD
Timepoint [5] 0 0
12 months (post T-cell infusion)
Secondary outcome [6] 0 0
Number of in-hospital days following first discharge post transplant
Timepoint [6] 0 0
12 months (post T-cell infusion)

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2017
Actual
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital Department of Haematology - Westmead, Sydney
Recruitment postcode(s) [1] 0 0
2145 - Westmead, Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02843321
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Gottlieb, Professor
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02843321