Alternate Donor Study of Pre-Emptive Cellular Therapy (CMV-ACE/ASPECT)
This study is currently recruiting participants.
Verified March 2013 by Cell Medica Ltd
Sponsor:
Cell Medica Ltd
Collaborators:
Leukaemia Lymphoma Research
National Health Service, Blood and Transplant
University of Birmingham
Information provided by (Responsible Party):
Cell Medica Ltd
ClinicalTrials.gov Identifier:
NCT01220895
First received: October 13, 2010
Last updated: March 12, 2013
Last verified: March 2013
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Purpose
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 cell transplantation (HSCT) for reducing recurrent CMV reactivation.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Infection |
Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective Phase 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 |
Resource links provided by NLM:
Further study details as provided by Cell Medica Ltd:
Primary Outcome Measures:
- Cytomegalovirus (CMV) specific immune reconstitution [ Time Frame: First two months ] [ Designated as safety issue: No ]Primary endpoint will be the peak number of circulating Cytomegalovirus (CMV)-reactive T cells within the first two months, after single positive cytomegalovirus PCR result (or post adoptive cell therapy infusion)
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ACT (mutlimer selection) plus standard therapy
Adoptive Cellular Therapy prepared using Multimer Selection in combination with standard best available antiviral drug therapy
|
Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result
|
| Active Comparator: Best available antiviral drug therapy |
Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220895
Contacts
| Contact: Karen Hodgkin | +44 207 554 4070 | karen.hodgkin@cellmedica.co.uk |
Locations
| United Kingdom | |
| QEH Birmingham Hospital | Recruiting |
| Birmingham, United Kingdom | |
| Principal Investigator: Frederick Chen | |
| Bristol Royal Hospital | Recruiting |
| Bristol, United Kingdom | |
| Principal Investigator: David Marks | |
| University College London Hospital | Recruiting |
| London, United Kingdom, WC1E 6BT | |
| Contact: Karl Peggs | |
| Principal Investigator: Karl S Peggs | |
| Kings College Hospital | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Tony Pagliuca | |
| Royal Free Hospital | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Ronjon Chakraverty | |
| The Christie | Recruiting |
| Manchester, United Kingdom | |
| Principal Investigator: Adrian Bloor | |
| Manchester Royal Infirmary | Recruiting |
| Manchester, United Kingdom | |
| Principal Investigator: John Yin | |
| Nottingham University Hospital - City Campus | Recruiting |
| Nottingham, United Kingdom | |
| Principal Investigator: Nigel Russell | |
| Churchill Hospital | Recruiting |
| Oxford, United Kingdom | |
| Principal Investigator: Andy Peniket | |
Sponsors and Collaborators
Cell Medica Ltd
Leukaemia Lymphoma Research
National Health Service, Blood and Transplant
University of Birmingham
Investigators
| Study Chair: | Karl S Peggs | University College London Hospital |
More Information
No publications provided
| Responsible Party: | Cell Medica Ltd |
| ClinicalTrials.gov Identifier: | NCT01220895 History of Changes |
| Other Study ID Numbers: | CM-2009-01 |
| Study First Received: | October 13, 2010 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Cell Medica Ltd:
|
Adoptive cellular therapy Hematopoietic Stem Cell Transplantation |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013