NCT00016068

Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation

A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
DRUG	ganciclovir
DRUG	valganciclovir

Timeline

• Start date: 2001-01-01
• Completion: 2007-09-01
• First posted: 2003-01-27
• Last updated: 2010-05-17

Locations

7 sites across 1 country: United States