CytoMegaloVirus~IMmunoProphylactic Adoptive Cellular Therapy study

A phase III randomised study to investigate the use of adoptive cellular therapy (ACT) in combination with conventional antiviral drug therapy for the treatment of cytomegalovirus reactivation episodes in patients following allogeneic haematopoietic stem cell transplant

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74928896

Enrollment

Registered

2008-03-04

Start date

2008-04-11

Completion date

Unknown

Last updated

2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus (CMV) infection in patients receiving allogeneic haematopoietic stem cell transplants (allo-HSCT) Infections and Infestations Cytomegalovirus (CMV)

Interventions

The study is divided into three arms. All patients receive current best available antiviral drug therapy when a positive CMV viraemia test is observed. Two arms of the study will additionally receive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Sibling T cell depleted allogeneic HSCT recipients where donor and recipient are both CMV seropositive 2. Aged 18 years or over

Exclusion criteria

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 (HIV) infection To be assessed prior to CMV-specific T cell infusion (confirmed prior to product release): 4. Active acute GVHD greater than grade I 5. Concurrent use of systemic corticosteroids 6. Organ dysfunction as measured by: 6.1. Creatinine greater than 200 uM/l 6.2. Bilirubin greater than 50 uM/l 6.3. Alanine aminotransferase (ALT) greater than three times normal

Design outcomes

Primary

Measure	Time frame
Number of patients experiencing a recurrent episode of CMV reactivation after primary reactivation, measured for six months post-ACT infusion.	—

Secondary

Measure	Time frame
1. Incidence and severity of GVHD, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion 2. Duration of antiviral drug therapy (total days) and of viraemia (total days), measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion 3. Incidence of CMV disease, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion 4. Laboratory evidence of reconstitution and persistence of CMV-specific immunity, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion	—

Measure

Time frame

1. Incidence and severity of GVHD, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion 2. Duration of antiviral drug therapy (total days) and of viraemia (total days), measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion 3. Incidence of CMV disease, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion 4. Laboratory evidence of reconstitution and persistence of CMV-specific immunity, measured at baseline, on a weekly basis for 100 days post infusion and then on a monthly basis up to six months post infusion

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026