NCT02843321

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

5.3 years

First QC Date

May 18, 2016

Last Update Submit

November 21, 2016

Conditions

Complication of Transplant

Keywords

infection

Outcome Measures

Primary Outcomes (1)

  • Safety of infection-specific T-cell infusion and vaccination

    Presence of acute infusion related toxicities

    1 week

Secondary Outcomes (6)

  • Change in infection specific immune reconstitution

    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

    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

    12 months (post T-cell infusion)

  • Use of systemic anti-fungal drugs including amphotericin and azoles

    12 months (post T-cell infusion)

  • Incidences of GVHD

    12 months (post T-cell infusion)

  • +1 more secondary outcomes

Study Arms (1)

T-cell infusion

EXPERIMENTAL

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

Biological: T-cell infusion, influenza vaccination

Interventions

T-cell infusion, influenza vaccinationBIOLOGICAL

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

T-cell infusion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Hospital Department of Haematology

Westmead, Sydney, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Infections

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • David Gottlieb, Professor

    Westmead Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2016

First Posted

July 25, 2016

Study Start

August 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)