Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation
- Conditions
- Infection
- Registration Number
- NCT00016068
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus.
PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.
- Detailed Description
OBJECTIVES:
Primary
* Compare cytomegalovirus (CMV) disease and non-CMV invasive infection-free survival in patients undergoing allogeneic hematopoietic stem cell transplantation treated with valganciclovir vs placebo.
* Compare the incidence of CMV disease in patients treated with these drugs.
* Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs.
Secondary
* Compare the incidence of CMV infection or disease at baseline and at days 270 and 640 after allogeneic hematopoietic stem cell transplantation in patients treated with these drugs.
* Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs.
* Determine the safety of valganciclovir in these patients.
* Compare the quality of life of patients treated with these drugs.
* Compare CMV-specific immune reconstitution in patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, prior neutropenia (yes vs no), and presence of refractory graft-versus-host disease requiring secondary therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral valganciclovir daily.
* Arm II: Patients receive oral placebo daily. Treatment begins around day 80-120 post-transplantation and continues until day 270 post-transplantation in the absence of active infection or unacceptable toxicity. Patients developing active cytomegalovirus (CMV) infection receive induction doses of ganciclovir IV or open-label oral valganciclovir for 1 week followed by open-label oral valganciclovir maintenance dosing until CMV can no longer be detected.
Quality of life is assessed at baseline and days 180 and 270 post-transplantation.
Patients are followed at days 400, 520, and 640 post-transplantation.
PROJECTED ACCRUAL: A total of 184 patients (92 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Late cytomegalovirus infection by plasma PCR positivity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States