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| CytoMegaloVirus~IMmunoProphylactic Adoptive Cellular Therapy study |
| Source of record | UK Trials |
| ISRCTN | ISRCTN74928896 |
| Date ISRCTN assigned | 04/03/2008 |
| Local reference number(s) | CM-2008-01 |
| Public title | CytoMegaloVirus~IMmunoProphylactic Adoptive Cellular Therapy study |
| Scientific title | 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 |
| Acronym | CMV~IMPACT |
| Disease/condition/study domain | Cytomegalovirus (CMV) infection in patients receiving allogeneic haematopoietic stem cell transplants (allo-HSCT) |
| Study hypothesis | Cytomegalovirus (CMV) infection is thought to result most frequently from reactivation of latent virus. Transmission of the virus can also occur from donor marrow infusion or from allogeneic red cell, leukocyte or platelet transfusions. In an allogeneic haematopoietic stem cell (bone marrow) transplant involving a patient who is CMV seropositive and/or receiving a transplant from a donor who is CMV seropositive, CMV frequently reactivates and disease resulting from the progression of infection is a major cause of infectious morbidity and mortality. CMV infection is a consequence both of the immunosuppression these patients receive and may also reflect delayed immune reconstitution in these patients following transplant. Hypothesis: Evaluation of the potential clinical benefit of prophylactic cytomegalovirus (CMV)-specific adoptive cellular therapy (ACT) following T cell depleted allogeneic haematopoietic stem cell transplant (HSCT) for reducing recurrent CMV reactivation. The study will investigate whether ACT will reduce the number of patients experiencing a recurrent episode of CMV reactivation after primary reactivation. |
| Design/methodology | Open label, randomised, multicentre study comparing immunoprophylaxis with adoptive cellular therapy (ACT). |
| Research ethics review | Ethics approval received from the Royal Free Hospital's Ethics Committee on the 20th February 2008. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Sibling T cell depleted allogeneic HSCT recipients where donor and recipient are both CMV seropositive 2. Aged 18 years or over |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 11/04/2008 |
| Anticipated end date | 10/10/2010 |
| Status of trial | Ongoing |
| Target number of participants | 112 from 11 centres |
| 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 prophylactic adoptive cellular therapy (ACT). The study is divided as follows: 1. 42 patients receiving standard best available antiviral drug therapy 2. 35 patients receiving ACT prepared using gamma catch selection in combination with standard best available antiviral drug therapy 3. 35 patients receiving ACT prepared using multimer selection in combination with standard best available antiviral drug therapy Treatment is a single dose ACT infusion at day 27 post-allo-HSCT, follow up is for six months post ACT infusion. |
| Primary outcome measure(s) | The primary measure will be the number of patients experiencing a recurrent episode of CMV reactivation after primary reactivation, measured for six months post-ACT infusion. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Wellcome Trust Technology Translation Award (UK) - dated 19th December 2006 |
| Sponsor name | Cell Medica Ltd (UK) |
| Sponsor details | 52 Norland Square London United Kingdom W11 4PZ |
| Contact name | Dr Karl Peggs |
| Contact details | UCL Cancer Institute Paul O'Gorman Building University College London 72 Huntley Street London United Kingdom WC1E 6BT |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN74928896 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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