NCT01077908

Brief Summary

The purpose of this study is to evaluate the potential clinical benefit of prophylactic cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

6.2 years

First QC Date

February 26, 2010

Last Update Submit

January 23, 2018

Conditions

Cytomegalovirus Infection

Keywords

Adoptive cellular therapyHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • CMV reactivations

    Six months

Study Arms (2)

ACT plus standard therapy

EXPERIMENTAL

Adoptive Cellular Therapy (ACT) prepared using Multimer or Gamma Catch Selection in combination with standard best available antiviral drug therapy

Biological: Adoptive Cellular TherapyDrug: Best available antiviral drug therapy

Best available antiviral drug therapy

ACTIVE COMPARATOR
Drug: Best available antiviral drug therapy

Interventions

Adoptive Cellular TherapyBIOLOGICAL

CMV-specific T-cells, single infusion at 27 days post-HSCT

ACT plus standard therapy
Best available antiviral drug therapyDRUG

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

ACT plus standard therapyBest available antiviral drug therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suitable participants will be selected from patients already scheduled to undergo a T cell depleted sibling donor HSCT. The criteria will include:
  • Age 18 years or older
  • Negative markers of Infectious Disease screen
  • Recipient of allogeneic HSCT (that incorporates T cell depletion with alemtuzumab) who is CMV seropositive with a CMV seropositive sibling donor
  • Informed consent from both donor and patient and to be assessed prior to CMV-specific T cell infusion (confirmed prior to product release):
  • Donor engraftment (neutrophils \> 0.5x109/l)

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 GVHD or its sequelae
  • HIV infection and to be assessed prior to CMV-specific T cell infusion (confirmed prior to product release):
  • Active acute GVHD \> Grade I
  • Concurrent use of systemic corticosteroids
  • Organ dysfunction as measured by
  • creatinine \> 200 uM/l
  • bilirubin \> 50 uM/l
  • ALT \> 3x upper limit of normal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Birmingham Heartlands Hospital

Birmingham, West Midlands, United Kingdom

Location

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, BS2 8BJ, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Royal Liverpool Hospital

Liverpool, United Kingdom

Location

University College Hospital

London, WC1E 6BT, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Christie Hospital

Manchester, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

City Hospital

Nottingham, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Karl S Peggs

    University College London Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 1, 2010

Study Start

July 1, 2008

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

GB(14)