T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant

Phase 2

• Conditions: Graft Versus Host Disease; Nonneoplastic Condition

• Registration Number: NCT00986557
• Lead Sponsor: University Hospital Birmingham

Brief Summary

RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant.

PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.

Detailed Description

OBJECTIVES:

Primary

* To determine the frequency of cytomegalovirus (CMV) reactivation during the first year after allogeneic stem cell transplantation (ASCT) in patients at risk for CMV infection treated with adoptive transfer of selected CMV-specific cytotoxic T-lymphocytes.

Secondary

* To monitor CMV-specific immune reconstitution within the first year following ASCT in these patients.

* To determine the time to CMV reactivation in these patients.

* To evaluate the use of antiviral therapy in these patients.

* To determine the incidence of secondary CMV reactivation and CMV disease in patients treated with this regimen.

* To determine the incidence of acute and chronic graft-versus-host disease.

OUTLINE: This is a multicenter study. After undergoing an allogeneic peripheral blood stem cell transplantation (PBSCT) using an alemtuzumab-based conditioning regimen that also includes radiotherapy, patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive cytomegalovirus (CMV)-specific cytotoxic T-lymphocyte infusion on day 21-90 after allogeneic PBSCT.

* Arm II: Patients undergo standard follow-up care and receive standard antiviral therapy comprising ganciclovir IV or foscarnet sodium upon detection or confirmation of CMV reactivation.

Blood samples are collected to assess CMV viral load by quantitative PCR.

After completion of study therapy, patients are followed once a week for 100 days and then once a month for 1 year.

PROJECTED ACCRUAL: A total of 18 patients with sibling donors and 21 patients with unrelated donors are accrued for each arm, resulting in a total of 78 patients accrued for this study.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Status Verified: 2010-04
• Primary Completion: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV reactivation in the first year after ASCT measured by quantitative PCR

Secondary Outcome Measures

Name	Time	Method
CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT
Time to CMV reactivation
Use of antiviral therapy
Incidence of secondary CMV reactivation and CMV disease
Incidence of acute and chronic graft-versus-host disease

Trial Locations

Locations (1)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust; 🇬🇧 Birmingham, England, United Kingdom