A trial of donor-derived cytotoxic T lymphocytes stimulated with an adenoviral vector containing the pp65 gene to prevent reactivation of cytomegalovirus following allogeneic stem cell transplantation for haematological malignancy

Infusion of Ad5f35pp65 stimulated donor-derived cytotoxic T lymphocytes for the prevention of cytomegalovirus reactivation following allogeneic stem cell transplantation for haematological malignancy

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000224426

Acronym

WM-CMV Adpp65-01

Enrollment

Registered

2007-04-27

Start date

2006-10-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Stem cell transplant recipients will receive an infusion of donor cells at least one month post transplant. Cells will have been stimulated in the laboratory so that they specifically recognise and kill parts of the viruses known as cytomegalovirus and adenovirus.

Interventions

Infusion of a single dose of in vitro stimulated lymphocytes at a dose of 2 x10^7/m2 over 5 minutes at 28 days post allogeneic stem cell transplant or beyond 28 days post allogeneic stem cell transplant if exclusion criteria prevent infusion on day 28. Infusion can be given up to 12 months post-transplant according to trial inclusion and exclusion criteria.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

myeloablative or non-myeloablative allogeneic stem cell transplant recipients receiving stem cells from an HLA identical or 1 antigen mismatched CMV seropositive donor. Adult patients judged eligible to undergo allogeneic stem cell transplant are eligible.

Exclusion criteria

CMV seronegative donor, current grade II-IV graft versus host disease, receiving prednisone or equivalent >1mg/kg/day.

Outcome results