Status:
COMPLETED
Alternate Donor Study of Pre-Emptive Cellular Therapy
Lead Sponsor:
Cell Medica Ltd
Collaborating Sponsors:
Leukaemia Lymphoma Research
National Health Service, Blood and Transplant
Conditions:
Cytomegalovirus Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the potential clinical benefit of pre-emptive cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem ...
Detailed Description
As with other herpes viruses, infection with CMV is thought to result primarily from reactivation of latent virus. Transmission of the virus can also occur from donor marrow infusion or from allogenei...
Eligibility Criteria
Inclusion
- Age 16 years or older
- cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor
- Patient Informed consent
- Prepared to undergo additional study procedures as per study schedule
- Patient has undergone counselling about risk
- Donor engraftment (neutrophils \> 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
- Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
- The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure.
- Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein.
- Healthy, Cytomegalovirus (CMV)seropositive donor - having passed medical for stem cell donation
- Subject and Donor must have negative serology for Human immunodeficiency virus (HIV), Hepatitis B and C, syphilis
- human leukocyte antigen (HLA) type A\*0101, A\*0201, A\*2402, B\*0702 and B\*0801
- Donor informed consent for stem cell mobilisation leucapheresis and storage
Exclusion
- Pregnant or lactating women
- Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae
- Human immunodeficiency virus infection
- Active acute Graft versus Host Disease (GVHD) \> Grade I (to be assessed prior to CMV-specific T cell infusion )
- Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion )
- Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by:
- creatinine \> 200 uM/l
- bilirubin \> 50 uM/l
- alanine transferase \> 3x upper limit of normal
- Donor pregnant or lactating
- Donor platelets \< 50x109/l
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01220895
Start Date
October 1 2010
End Date
January 1 2014
Last Update
January 25 2018
Active Locations (9)
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1
QEH Birmingham Hospital
Birmingham, United Kingdom
2
Bristol Royal Hospital
Bristol, United Kingdom
3
University College London Hospital
London, United Kingdom, WC1E 6BT
4
Kings College Hospital
London, United Kingdom