CytoMegaloVirus: Alternate donor Study of Pre-Emptive Cellular Therapy

Phase 1

Completed

• Conditions: Cytomegalovirus; Infections and Infestations; Cytomegaloviral disease

• Registration Number: ISRCTN75391842
• Lead Sponsor: Cell Medica Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-23
• Study Completion: 2014-02-01
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Incidence and severity of GvHD<br> 2. The earliest detection of CMV-reactive T cells in the peripheral blood<br> 3. Duration of CMV antiviral drug therapy (total days), number of in-patient days and number of reactivation episodes<br><br> All measured on a weekly basis for the first 100 days following infusion and then monthly up to 6 months thereafter.<br>