T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
Recruitment status was: Recruiting
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.
Graft Versus Host Disease
Biological: adoptive immunotherapy
Biological: in vitro-treated peripheral blood lymphocyte therapy
Drug: foscarnet sodium
Genetic: polymerase chain reaction
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: infection prophylaxis and management
Procedure: peripheral blood stem cell transplantation
Procedure: standard follow-up care
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomised Controlled Phase II Trial of the Adoptive Transfer of Selected Cytomegalovirus-Specific Cytotoxic T Lymphocytes (CMV-CTL) After Allogeneic Stem Cell Transplantation (SCT) in Patients at Risk of CMV Disease|
- CMV reactivation in the first year after ASCT measured by quantitative PCR [ Designated as safety issue: No ]
- CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT [ Designated as safety issue: No ]
- Time to CMV reactivation [ Designated as safety issue: No ]
- Use of antiviral therapy [ Designated as safety issue: No ]
- Incidence of secondary CMV reactivation and CMV disease [ Designated as safety issue: No ]
- Incidence of acute and chronic graft-versus-host disease [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986557
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust|
|Birmingham, England, United Kingdom, B15 2SG|
|Principal Investigator:||Frederick Chen, MD||University Hospital Birmingham|