Condition category
Infections and Infestations
Date applied
02/04/2009
Date assigned
23/04/2009
Last edited
03/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Karl Peggs

ORCID ID

Contact details

UCL Cancer Institute
Paul O'Gorman Building
University College London
72 Huntley Street
London
WC1E 6BT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01220895

Protocol/serial number

CM-2009-01

Study information

Scientific title

A prospective phase I/II study to investigate the efficacy and safety of pre-emptive cytomegalovirus adoptive cellular therapy in patients receiving allogeneic haematopoietic stem cell transplant from an unrelated donor

Acronym

CMV: ASPECT

Study hypothesis

The study will test the hypothesis that adoptive cellular therapy (ACT) can augment the impaired cytomegalovirus (CMV) immune function post-transplant and reduce the requirement for CMV antiviral drug therapy without causing an increase in graft-versus-host disease (GvHD).

On 24/07/2013 the overall trial end date was changed from 31/05/2011 to 01/02/2014.

Ethics approval

Submitted to University College London Hospitals Research Ethics Committee (UCLH REC) Alpha for review on 07/05/2009 (ref: 09/H0715/47) – approval pending

Study design

Open label randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cytomegalovirus

Intervention

Patients will be randomised to receive pre-emptive infusion of gamma-captured CMV-specific T-cells administered upon first CMV PCR+ result, along with standard monitoring and pre-emptive CMV anti-viral drug therapy as required (treatment arm A) or standard CMV anti-viral drug therapy alone (treatment arm B) in the ratio of 2:1.

The patient will be assessed for CMV viraemia on a weekly basis up to 100 days following HSCT. On presentation of CMV viraemia the patient will receive the ACT infusion within 72 hours. They will then be assessed on a weekly basis up to 70 days post-infusion and monthly thereafter up to six months. Patients in the control arm will be followed up on a weekly and monthly basis as before but will not receive the ACT infusion.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The percentage of patients with a peak number of circulating CMV-reactive T-cells above 10 x 10^6/l within the first two months post single positive PCR result (or ACT infusion), measured in the first two months following ACT infusion.

Secondary outcome measures

1. Incidence and severity of GvHD
2. The earliest detection of CMV-reactive T cells in the peripheral blood
3. Duration of CMV antiviral drug therapy (total days), number of in-patient days and number of reactivation episodes

All measured on a weekly basis for the first 100 days following infusion and then monthly up to 6 months thereafter.

Overall trial start date

01/06/2009

Overall trial end date

01/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 years or older, either sex
2. Allogeneic T-cell depleted (alemtuzumab-containing conditioning regimen) haematopoietic stem cell transplant (HSCT) recipient with CMV seropositive unrelated donor
3. Informed consent:
3.1. Prepared to undergo additional study procedures as per study schedule
3.2. Patient has undergone counselling about risk

To be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
4. Donor engraftment (neutrophils greater than 0.5 x 10^9/l)
5. Single positive CMV polymerase chain reaction (PCR) result

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18

Participant exclusion criteria

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. Human immunodeficiency virus (HIV) infection

To be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
4. Active acute GvHD greater than Grade I
5. Concurrent use of systemic corticosteroids
6. Organ dysfunction as measured by:
6.1. Creatinine greater than 200 uM/l
6.2. Bilirubin greater than 50 uM/l
6.3. Alanine aminotransferase (ALT) greater than 3 x upper limit of normal

Recruitment start date

01/06/2009

Recruitment end date

01/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Cancer Institute
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

Cell Medica Ltd (UK)

Sponsor details

27 Fitzroy Square
London
W1T 6ES
United Kingdom

Sponsor type

Industry

Website

http://www.cellmedica.co.uk/

Funders

Funder type

Industry

Funder name

Cell Medica Ltd (UK) - provide indemnity, prepare the ACT product and subsidise the performance of immune reconstitution assays

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Miltenyi Biotec (Germany) - subsidising some materials and reagents used

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Free and University College London (UK) - Haematology Department will pick up additional costs associated with participation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes