CytoMegaloVirus~IMmunoProphylactic Adoptive Cellular Therapy study

Phase 3

Completed

• Conditions: Cytomegalovirus (CMV) infection in patients receiving allogeneic haematopoietic stem cell transplants (allo-HSCT); Infections and Infestations; Cytomegalovirus (CMV)

• Registration Number: ISRCTN74928896
• Lead Sponsor: Cell Medica Ltd (UK)

Brief Summary

2014 results abstract in: http://www.bloodjournal.org/content/124/21/1109 [added 10/05/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-04
• Study Completion: 2014-08-01
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Sibling T cell depleted allogeneic HSCT recipients where donor and recipient are both CMV seropositive
2. Aged 18 years or over

Exclusion Criteria

1. Pregnant or lactating women
2. Co-existing medical problems that would place the patient at significant risk of death due to graft-versus-host disease (GVHD) or its sequelae
3. Human immunodeficiency virus (HIV) infection

To be assessed prior to CMV-specific T cell infusion (confirmed 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 three times normal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients experiencing a recurrent episode of CMV reactivation after primary reactivation, measured for six months post-ACT infusion.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Incidence and severity of GVHD, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion<br> 2. Duration of antiviral drug therapy (total days) and of viraemia (total days), measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion<br> 3. Incidence of CMV disease, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion<br> 4. Laboratory evidence of reconstitution and persistence of CMV-specific immunity, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion<br>