CMV Impact Study

A phase III randomised study to investigate the use of adoptive cellular therapy (ACT) in combination with conventional antiviral drug therapy for the treatment of CMV reactivation episodes in patients following allogeneic haematopoietic stem cell transplant

Suitable participants will be selected from patients already scheduled to undergo a T cell depleted sibling donor HSCT. The criteria will include:

1. Age over 18 years
2. Laboratory tests as described in Appendix 15.
3. Recipient of allogeneic HSCT (that incorporates T cell depletion with alemtuzumab) who is
CMV seropositive with a CMV seropositive sibling donor
4. Informed consent from both donor and patient 
and to be assessed prior to CMV-specific T cell infusion (confirmed prior to product release):

5. Donor engraftment (neutrophils > 0.5x10/l)

Eligible sibling donors will have already passed a medical for stem cell donation. The donor
inclusion criteria will include:

1. Donor must have met requirements of EU Tissue and Cells Directive (2004/23/EC) as
amended and the UK statutory instruments pursuant therein.
2. Laboratory tests as described in Appendix 15.
3. Healthy donor – having passed medical for stem cell donation
4. CMV seropositive
5. Negative serology for HIV (type 1 & 2), Hepatitis B and C, Syphilis
6. Informed consent from both donor and patient

1. Pregnant or lactating women
2. Co-existing medical problems that would place the patient at significant risk of death due to
GVHD or its sequelae
3. HIV infection
and to be assessed prior to CMV-specific T cell infusion (confirmed prior to product release):

4. Active acute GVHD > Grade I
5. Concurrent use of systemic corticosteroids
6. Organ dysfunction as measured by
a. creatinine > 200 uM/l
b. bilirubin > 50 uM/l
c. ALT > 3x normal

Eligible sibling donors will have already passed a medical for stem cell donation. The donor exclusion criteria will include:

1. Pregnant or lactating

And to be assessed prior to harvest of CMV-specific T cells:               2. Platelets < 50x10/l

Principal Investigator

Dr Gordon Cook

Tel 0113 2068433

Email gordon.cook@leedsth.nhs.uk

Research Nurse

Alex Stichler

Tel 0113 2068577

Email alex.stichler@leedsth.nhs.uk

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