ISRCTN75391842
Completed
Phase 1
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
Cell Medica Ltd (UK)0 sites18 target enrollmentApril 23, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cell Medica Ltd (UK)
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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