CytoMegaloVirus: Alternate donor Study of Pre-Emptive Cellular Therapy

ISRCTN	ISRCTN75391842
DOI	https://doi.org/10.1186/ISRCTN75391842
ClinicalTrials.gov number	NCT01220895
Secondary identifying numbers	CM-2009-01

Submission date: 02/04/2009
Registration date: 23/04/2009
Last edited: 13/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-treatment-cytomegalovirus-after-stem-cell-bone-marrow-transplant-cmv-impact

Contact information

Dr Karl Peggs
Scientific

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

Study information

Study design	Open-label randomised study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	CMV: ASPECT
Study objectives	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).
Ethics approval(s)	Submitted to University College London Hospitals Research Ethics Committee (UCLH REC) Alpha for review on 07/05/2009 (ref: 09/H0715/47) – approval pending
Health condition(s) or problem(s) studied	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	Biological/Vaccine
Pharmaceutical study type(s)
Phase	Phase I/II
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/06/2009
Completion date	01/02/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	18
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	01/07/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UCL Cancer Institute

London
WC1E 6BT
United Kingdom

Sponsor information

Cell Medica Ltd (UK)
Industry

27 Fitzroy Square
London
W1T 6ES
United Kingdom

Website	http://www.cellmedica.co.uk/
"ROR"	https://ror.org/027q99w81

Funders

Funder type

Industry

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

No information available

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/03/2019: No publications found, verifying study status with principal investigator.
02/06/2017: No publications found, verifying study status with principal investigator.
24/07/2013: The overall trial end date was changed from 31/05/2011 to 01/02/2014.