Alternate Donor Study of Pre-Emptive Cellular Therapy

NCT01220895 | Completed Phase 2 DMC

• 1 other identifier: CM-2009-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 9

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 cell transplantation (HSCT) for reducing recurrent CMV reactivation.

Conditions

Cytomegalovirus Infection

Keywords

Adoptive cellular therapy; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Cytomegalovirus (CMV) specific immune reconstitution

  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)

  First two months

Study Arms (2)

ACT (mutlimer selection) plus standard therapy

EXPERIMENTAL

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

Best available antiviral drug therapy

ACTIVE COMPARATOR

Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result

Interventions

CMV-specific T-cells, single infusion following single positive CMV PCR result BIOLOGICAL

1. Intravenous ganciclovir 5mg/kg twice daily 2. Oral valganciclovir 900mg twice daily 3. Intravenous foscarnet 90 mg/kg twice daily

ACT (mutlimer selection) plus standard therapy; Best available antiviral drug therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cell Medica Ltd: lead
• Leukaemia Lymphoma Research: collaborator
• National Health Service, Blood and Transplant: collaborator
• University of Birmingham: collaborator

Study Sites (9)

QEH Birmingham Hospital

Birmingham, United Kingdom

Location

Bristol Royal Hospital

Bristol, United Kingdom

Location

University College London Hospital

London, WC1E 6BT, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

The Christie

Manchester, United Kingdom

Location

Nottingham University Hospital - City Campus

Nottingham, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Karl S Peggs

  University College London Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

GB (9)