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Alternate Donor Study of Pre-Emptive Cellular Therapy (CMV-ACE/ASPECT)

This study has been completed.
Sponsor:
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: May 14, 2014
Last verified: May 2014
  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
Study Completion Date: January 2014
Primary Completion Date: December 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
  1. Intravenous ganciclovir 5mg/kg twice daily
  2. Oral valganciclovir 900mg twice daily
  3. Intravenous foscarnet 90 mg/kg twice daily
Active Comparator: Best available antiviral drug therapy Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result
  1. Intravenous ganciclovir 5mg/kg twice daily
  2. Oral valganciclovir 900mg twice daily
  3. Intravenous foscarnet 90 mg/kg twice daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 16 years or older
  2. cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor
  3. Patient Informed consent

    1. Prepared to undergo additional study procedures as per study schedule
    2. Patient has undergone counselling about risk
  4. Donor engraftment (neutrophils > 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
  5. Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
  6. The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure.
  7. Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein.
  8. Healthy, Cytomegalovirus (CMV)seropositive donor - having passed medical for stem cell donation
  9. Subject and Donor must have negative serology for Human immunodeficiency virus (HIV), Hepatitis B and C, syphilis
  10. human leukocyte antigen (HLA) type A*0101, A*0201, A*2402, B*0702 and B*0801
  11. Donor informed consent for stem cell mobilisation leucapheresis and storage

Exclusion Criteria:

  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 infection
  4. Active acute Graft versus Host Disease (GVHD) > Grade I (to be assessed prior to CMV-specific T cell infusion )
  5. Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion )
  6. Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by:

    1. creatinine > 200 uM/l
    2. bilirubin > 50 uM/l
    3. alanine transferase > 3x upper limit of normal
  7. Donor pregnant or lactating
  8. Donor platelets < 50x109/l
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220895

Locations
United Kingdom
QEH Birmingham Hospital
Birmingham, United Kingdom
Bristol Royal Hospital
Bristol, United Kingdom
University College London Hospital
London, United Kingdom, WC1E 6BT
Royal Free Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
The Christie
Manchester, United Kingdom
Nottingham University Hospital - City Campus
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
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: May 14, 2014
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
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014