A phase III randomised study to investigate the use of adoptive cellular therapy (ACT) in combination with conventional antiviral drug therapy for the treatment of cytomegalovirus reactivation episodes in patients following allogeneic haematopoietic stem cell transplant

Cell Medica Ltd (UK)0 sites75 target enrollmentMarch 4, 2008

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cytomegalovirus (CMV) infection in patients receiving allogeneic haematopoietic stem cell transplants (allo-HSCT)
Sponsor: Cell Medica Ltd (UK)
Enrollment: 75
Status: Completed
Last Updated: 6 years ago

Registry

who.int

Start Date

March 4, 2008

End Date

August 1, 2014

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Cell Medica Ltd (UK)

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

•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