CompletedPhase 2

Alternate Donor Study of Pre-Emptive Cellular Therapy

United Kingdom52 participantsStarted 2010-10

Plain-language summary

The purpose of this study is to evaluate the potential clinical benefit of pre-emptive cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. Age 16 years or older
✓. cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor
✓. Patient Informed consent
✓. Prepared to undergo additional study procedures as per study schedule
✓. Patient has undergone counselling about risk
✓. Donor engraftment (neutrophils \> 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
✓. Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
✓. The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure.

Exclusion criteria

✕. Pregnant or lactating women
✕. Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae
✕. Human immunodeficiency virus infection
✕. Active acute Graft versus Host Disease (GVHD) \> Grade I (to be assessed prior to CMV-specific T cell infusion )

What they're measuring

Cytomegalovirus (CMV) specific immune reconstitution

Timeframe: First two months

Trial details

NCT IDNCT01220895

SponsorCell Medica Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Cytomegalovirus Infection trials